Resume template for clinical research associate

Managed qualitative data and performed qualitative analysis using Nvivo 8. Assisted with writing manuscripts for journal submissions and abstracts for professional conferences. Monitored regulatory reviews including IRB, and participated in protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance. Conducted literature reviews for manuscript planning and conducted orientation of additional qualitative staff.

Developed study training materials and facilitated trainings with study team and sites as needed. Clinical Research Associate III Resume Summary : Consistently working to achieve or exceed management goals and objectives; excellent interpersonal and communication skills at all levels of the organization, with associates and patients; quickly adapt to new policies, procedures and protocols.

Description : Coordinate with the collection, distribution, and storage of data obtained during clinical research trials, for the testing of drugs and medical products. Ensured that trials stay on track with clinical objectives and complies with federal regulations, analyze data, create comprehensive reports, make presentations and monitor individual cases.

Performed CRF review; query generation and resolution against established data review guidelines data management systems. Ensure study staff conducting the protocol have received the proper materials, instructions, and training to safely enter subjects into the study and complete the protocol requirements, as written.

Identified and completed follow-up of Serious Adverse Events at assigned study sites. Ensured the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

Ensure that the Site Regulatory Documents are complete and current through trial. Description : Responsible for all aspects of site management from site selection to site close out.

Involved in the investigator site identification process and performed site evaluation visits to ascertain site's capabilities and suitability to conduct the clinical trial. Managed the site regulatory submission process to ensure that all bottlenecks are ironed out and that delay of the clinical trial campaign is avoided.

Conducted presentations and trained site personnel during Investigator Meetings. Performed ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication. Performed troubleshooting and problem solving tasks at sites to help achieve turnaround results.

Training and re-training of new research personnel, including Study Coordinators, Investigators, and site pharmacists as required during the study. Skills : Power point, Multitasking, Microsoft office, excel.

Carried out site-initiation visits and ensured that all study materials such as updated protocols, investigator brochures, instructions and investigational product is received by the site. Trained the investigator and staff regarding Study protocol and conduct via presentations, informational handouts and group discussions, identified any study related issue and suggested corrective measures if any or escalated the issue to the Manager as needed.

Ensured the subject enrollment, advertising for the study, ICF process, reviewed EDC against source data such as patient diaries, laboratory results, scans etc. Ensured all the essential documents are maintained in the investigator site folder and is updated with new or amended documents and essential documents are forwarded to the sponsor for updating the TMF as necessary. Documented all findings and activities at the site and complete a monitoring visit report and submit to the Manager.

Description : Responsible for reviewing and tracking of study essential documents e. Review and track regulatory documents and the verification of data management queries to meet clinical study timelines.

Monitor clinical studies in accordance with sponsor's protocol and GCPs to assess the safety and efficiency of investigational products. Applying FDA regulations and ICH-GCP guidelines to all aspects of clinical studies including but not limited to: protocol compliance, IRB submissions, ICF review, handling adverse events to ensure safety and protection of study participants and enhanced data credibility. Track and monitor enrollment at sites, initiating additional recruitment and retention strategies as required.

Manage time effectively in order to fulfill requirement to meet all timelines, in both therapeutic work and submission of administrative documents. Description : Participate in site pre-study, initiation, routine monitoring, and study closeout visits in-line with SOPs and Protocols.

Compile reports to quality standards within company specified timelines. Provide quality overview and consistency check on all developed ICFs and completes the informed consent checklist. Creating, maintaining, and reviewing monitoring standard operating procedures, monitoring tools for conducting monitoring tasks including: monitoring plans, monitoring reports, corrective and preventive action plans.

Conduct training for investigative site personnel on study protocols and visit procedures Acts as primary liaison for assigned study sites while to convey project information. Skills : In-depth knowledge of clinical research procedures,. Description : Conduct monitoring visits to perform on-site review of files and records for source document verification and review of case report forms for completeness, accuracy, consistency and Protocol compliance.

Perform drug accountability to ensure adequate storage, dispensing and use of investigational product at the site. Conduct pre-study visits to evaluate the suitability of investigational sites for the investigation study and ensured the availability of facilities, resources, and qualified and experienced personnel.

Review Serious Adverse Event SAE reports and ensured that appropriate reporting procedures were performed within the required time frame. Perform routine monitoring visits according to the monitoring plan to ensure site adherence to protocol and all study guidelines.

Conduct initiation visits to open up investigational sites for clinical studies and ensured the investigational product has been received and that all study supplies and equipment have been received and ready for the commencement of the study. Skills : Aspectic Technique. Description : Travel performing on-site monitoring visits, including site selection, site initiation, periodic, close out and corrective action visits. Independently performs monitoring activities for multiple sites and multiple projects, identifying deviations from regulations and SOPs.

Evaluates protocol and regulatory compliance, including source document verification, informed consent process, human subject protection, data integrity, drug accountability, compliance, review of investigator and regulatory files. Provides study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations.

Identify action items, subject safety, data integrity issues and retrain site personnel accordingly. Communicates routine and unusual findings to trial supervisor. Independently documents routine site management and ongoing follow-up, clinical monitoring activities, site communication and trial related activities.

Provides knowledge of protocol, study documents and processes, during monitoring activities. Collaborates with colleagues and clinical sites to develop and execute corrective action plans Ensures training is completed per the required timelines and project needs Identifies process improvement opportunities.

Prepares clinical documents, business correspondence, and procedural manuals. Maintain systems and process necessary to report trial status and activities; and to help ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.

Educate patients about clinical research protocols, study requirements and expectations Adhere to legal, professional and ethical codes with respect to confidentiality and privacy Collaborate with other members of the research team to ensure consistent practice in patient care management Monitor on-site study sites to meet with, assist and consult with study investigators Recruit and schedule all study site personnel as required Track the expenditures for all study-related activities, including supplies and equipment Create study documents, including protocols and amendments thereof, consent forms, data collections forms Provide inputs to final reports that document the research findings for human use protocols including, but not limited to those listed above.

Communication - Maintains timely and effective communication among team members and site staff. Keeps project leadership apprised of team issues, seeking guidance as needed. Assures timely and accurate completion of Data Clarification Forms. Maintains awareness of key study performance indicators for own sites, e. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit Administrative - Prepares for and attends Investigator meetings.

May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested.

Maintains current regulatory documentation according to Essential Regulatory Document Guidelines. Participates in TMF and on-site audits as requested; may require guidance to. Previous clinical or related research experience preferred. Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.

Native fluency in Japanese language speaking, reading and writing and able to handle business level English. May represent Regional Associate Directors and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings e. Responsible for collecting regulatory documents from site and filing in the Novartis Trial Master File.

Prepare and collect study site documents Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF or eCRF completion, SAE reporting, GCP, and possibly the drug mechanism Responsible for utilizing and updating electronic systems to perform job functions e. Serve as a reference to other CRAs on electronic systems.

May be responsible for assisting with the evaluation, design and implementation of new systems Ensure that study milestones are met as planned i. May review and approve monitoring reports of junior CRAs as assigned Manage data query resolution process with sites and track status updates i. IWS Perform Site Closeout activities per SOPs and applicable regulations Travel domestically and possibly internationally as needed to study sites and for training and meetings.

Assist in and participate, plan, and lead study training meetings e. Ensure that all data and data collection from clinical research are handled according to applicable regulations and guidelines Maintain dedicated investigation files to audit and inspection standards Write protocols, amendments, case record forms, clinical reports and other documents relevant for dedicated clinical investigations.

Encourages collaborative behavior; delegates effectively; and empowers others to take action. Gives effective feedback. Acts with fairness. Actions and words are congruent. Exhibits a high level of flexibility and sets an example for adaptability for changing priorities and processes Employs strong fiscal management of departmental budget by independently managing travel and functional expenses Demonstrates strong project management skills when engaging with stakeholders to ensure efficient management of timelines, resources, encountered challenges and stakeholders Serves a role model for department through active planning, participation and representation on various projects, initiatives involving a wide breadth of internal and external stakeholders Ability to manage successfully with designated book of work, adjust accordingly for risk based monitoring practices using critical thinking skills, and prioritize actionable items as necessary Support Clinical Trial Managers by coordinating necessary activities required for setting up investigational sites and monitoring a clinical study, completing accurate study status reports and maintaining study documentation Update clinical trial management systems Initiates, maintains and reconciles the sponsor study files in accordance with Standard Operating Procedures SOPs Process site payments Collects and reviews regulatory documents from clinical sites Maintain tracking logs for departmental activities i.

Confirms the qualifications of investigators, medical centers, and investigational sites throughout the conduct of a program and assesses adherence to Good Clinical Practice GCP. Independently monitors clinical study sites: documents all findings, outcomes and agreements reached during site visits. Resolves discrepancies and ensures proper maintenance of site's documentation Participates in co-monitoring visits Participates in study meetings Periodically reviews adverse events reported in the study and works with Pharmacovigiliance colleagues on reconciliation of safety databases.

Oversees the required communication to the investigators as per the regulatory guidelines Manages data discrepancies for assigned sties and coordinates the clinical monitoring activities to ensure that these discrepancies are resolved in the established timeframe for resolution Manages laboratory specimen collection process where applicable including interfacing with laboratory and vendors.

Minimum years experience as a CRA or other related experience in the health care, biotechnology, diagnostics, or other relevant industry; related experience may include clinical trial assistant, project assistant, study assistant or study coordinator Demonstrated competence with Microsoft tools, specifically Word; Excel; PowerPoint; and Project Well-organized and detail oriented Strong oral and written communicator with ability to maintain open communication with internal employees, managers and customers as needed.

Minimum of 3 years monitoring experience with at least 1 year experience of monitoring Oncology studies in the U. A Excellent time management, project management, organizational, and communication skills written and verbal in local language and English Expertise in and excellent working knowledge of core systems and tools Preferred candidate will reside within the territory.

Arranging on-site visits and logistics Establishment of a site recruitment plan in collaboration with site staff during QV Performing site documentation verification Data collection and drug accountability in accordance with ICH GCP guideline Monitoring patient safety on-site and addressing any violations in a timely manner Competent in written and oral English and Polish.

Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with Mylan document control procedures for each project Review all clinical and drug product documents for accuracy, completeness and timeliness internally and at the research sites. This includes visit preparation, monitoring process, completion of the monitoring report, visit follow-up activities and travel to and from the clinical locations Interview clinical site research personnel in follow-up of monitoring visits and data issues.

Knowledge of and understanding of Good Clinical Practice and other associated regulations, guidelines and industry standards for clinical trials is required.

Knowledge of medical terminology is desired Must possess excellent oral and written communication skills. Good organization skills, attention to detail, ability to work as part of a team and the ability to manage multiple tasks is required. Must possess planning skills for a range of 6 months to 2 years in advance of study deadlines.

Should have the ability to read and interpret documents. Ability to write routine reports and correspondence. The successful candidate must maintain a high level of professionalism and personal integrity Ability to perform computations such as percentages, ratios, and rates. Ability to understand simple statistical analyses Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis.

Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. As key member of the project team, the LCRA supports the development of the Monitoring plan and pays special attention to the adherence of the monitoring plan A higher education degree in a scientific, health care, or other related discipline required Minimum of 5 years field monitoring experience Excellent knowledge of written and spoken English and local language as applicable Expertise in communication, managing multiple priorities and computer literacy, supervisory and organizational skills Desirable other European language Understands and can apply knowledge of clinical trial designs to trial execution.

You should thrive in project teams and be focused on delivering exemplary levels of customer service You will perform and coordinate all aspects of the clinical monitoring process Effective oral and written communication skills, with the ability to communicate effectively with medical personnel.

Fluency in English and in the country's native language Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures Skills to mentor and train other monitors in a positive and effective manner Excellent team player with team building skills Effective presentation skills.

Considerable clinical research monitoring experience comparable to 5 years with a demonstrated high level of expertise in all aspects of clinical monitoring Expert clinical monitoring skills Fluency in French, both written and spoken. Works with site personnel and study team to identify resolve and prevent issues Oversees monitoring activities for a study to ensure the accurate reporting of high quality data and timely query resolution; ensure data is collected from sites within given timelines Presents at and participates in Investigator Meetings, other study trainings and meetings as required Ensures quality of data in the event that a site or CRA performance issue has been identified at a previously monitored site Proactively prevents and identifies issues including study processes, monitoring or site issues Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables Develops the study Monitoring Plan and ensures CRA compliance with visit frequency and all assigned tasks throughout the study.

Escalates CRA noncompliance to Study managers promptly Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization Oversees site start-up activities, including site selection and regulatory document collection, review, approval and tracking Develops study specific CRA training materials.

Trains CRA team and tracks and maintains documentation of training throughout the life of the project Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues e. Works with CSM to assure investigator payments are appropriate and paid on a timely basis if applicable.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

Carry out assigned functions applying knowledge and skill in an accurate, timely manner Perform specialized tasks as trained in an independent fashion, requiring minimal ongoing direction. Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May coordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives.

Should be able to understand the relevant sections of the study protocol. Other languages are a bonus. Assist in development of protocol, ICF, CRF, CRF completion guidelines, preparation and maintenance of monitoring plans, study binders, study manuals, and other site specific and monitoring tools Request and collect initial regulatory documentation Ensure that sites fulfill their regulatory obligations and submit study documents for IRB review and approval Perform study tracking and reports progress in a timely manner Plan and conduct training, site initiation, interim and close-out visits.

Minimum BS in scientific discipline or equivalent. Able to produce accurate and well-presented documents. Interpersonal and organizational skills are a must.

Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation Identify potential investigators, prepare site budgets and contract agreements Prepare study protocols investigator manuals, site specific instruction manuals and design case report forms for new and modified products Assist with the management of key study parameters i.

Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem Stay up to date on major advances in infectious disease diagnosis, cancer detection and the use of new tests and advances in clinical practice The ideal candidate will have the following.

Participates in TMF and on-site audits as requested. Responds to findings without oversight. Performs clinical data listings reviews as needed Administrative - Prepares for and attends Investigator meetings. Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF or eCRF completion, SAE re-porting, GCP, and possibly the drug mechanism Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials.

Nominate sites to participate in studies in con-junction with Medical Science Liaison MSL and Clinical Research Medical Advisor CRMA colleagues Computer literacy and proficiency Ability to multi-task and prioritize multiple high-priority projects, site questions, CRA questions, and clinical team inquiries while managing responsibilities and deadlines.

Bachelor's degree required Advanced degree or certification preferred but not required Minimum 5 years of experience in similar role eg. Prepare study monitoring reports, per Standard Operation Procedures SOPs and applicable regulations Attend disease indication and project specific training and general CRA training as required.

May participate in the training of other CRAs at meetings Perform additional roles and functions for GenMed Clinical Operations as assigned such as a Trial Lead CRA, systems superuser, or committee member Up to 2 years of prior experience in a clinical research role as either a CRA or site CRC or relevant experience Demonstrated ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to Management or Clinical Team.

Experience creating study documents Enrollment experience. Ability to maintain customer focus through the utilization of good listening skills, attention to detail Ability to remain flexible and adaptable in a wide range of scenarios Good computer skills: proficient knowledge of Microsoft Office and the ability to learn appropriate software Monitors investigator sites to ensure the accuracy and validity of CRF entries in Participates in investigator meetings as necessary.

Identifies potential. Competent in independent drug accountability Competent in independent investigator site file review Demonstrates understanding of all Essential Documents and their collection and maintenance Off-site experience: familiarity with basic category of Clinical Monitoring Associate tasks. Demonstrate proficiency in navigation within: CTMS systems, Data Platforms for projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems Model professional communication in both written and verbal interactions Demonstrate sufficient time management to achieve required deliverables Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Knowledge of clinical trial practices and regulations Knowledge of clinical monitoring and trial design College Degree and minimum of years of clinical research experience. Monitoring experience is a plus. Responsible for data monitoring and study site management Work according to Good Clinical Practice, rules and regulations and internal procedures Support site identification, selection, i. This includes amongst others the receipt of necessary documentation for the Trial Master Files TMF as well as TMF maintenance, control of budget, communication with and to Clinical Research Organizations CROs , Laboratories, and other external vendors involved in the conduct of studies.

Performs ongoing reconciliation of the Trial Master File TMF content to site files Primary contact for study site personnel Provide training to site personnel Track and report progress of study sites Responsible for quality data from study sites. Ensures appropriate source documentation, training, and accurate transcription of data into the study Case Report Form CRF as evidenced by minimal data query rates.

Have a working knowledge of the relevant SOPs Have the necessary interpersonal and communication skills to establish professional working relationships with colleagues and site personnel Attention to detail and the ability to prioritize. Strong organizational, planning and follow-through skills Ability to work well under pressure and with tight schedules Ability to exercise judgment within generally defined practices and policies for obtaining data Self-direction and motivation are mandatory MS Word, Excel, in-depth knowledge of other presentation programs a plus Must be available to work in the evenings and weekends, as required Must have the quality-service attitude and be willing to work additional hours to meet deadlines.

Participates in the design and monitoring of clinical trials Analyzes and evaluates clinical data gathered during research. Ensures compliance with protocol and overall clinical objectives Performs a variety of complicated tasks Typically reports to a supervisor or manager Knowledge of FDA regulatory requirements is required Familiar with a variety of the field's concepts, practices, and procedures in a clinical research setting.

Participates in the design, administration and monitoring of clinical trials Analyzes and evaluates clinical data gathered during research Ensures compliance with protocol and overall clinical objectives Relies on instructions and pre-established guidelines to perform the functions of the job Works under immediate supervision Primary job functions do not typically require exercising independent judgment Knowledge of commonly-used concepts, practices, and procedures within a clinical research setting.

Assess adequacy of potential clinical investigators and clinical trial sites. Experience in Immunology monitoring is preferred Proven strong site management and monitoring skills Good negotiating skills, tact and diplomacy. Perform site selection if applicable , initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.

Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

Escalate quality issues as appropriate Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form CRF completion and submission, and data query generation and resolution.

May support start-up phase Act as a mentor for clinical staff including conducting co-monitoring and training visits May provide assistance with design of study tools, documents and processes Strong knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.

Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study Reviews the quality and integrity of the clinical data through 1 in house review of electronic CRF data and 2 on-site source verification.

Perform site evaluation visits, as needed, of potential investigators. Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study.

Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Ensures regulatory inspection readiness at assigned clinical sites Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives.

The main purpose of this role will be to perform all required activities to ensure appropriate monitoring of investigator sites and study execution under the supervision the Manager Clinical Field Operation The Senior Clinical Research Associate SCRA implements and coordinates assigned clinical research projects in EMEAC The SCRA ensures that activities are conducted in accordance with the internal quality system and external guidelines and regulations.

SCRA ensures that the projects are conducted according to protocol and associated documents and that agreed study milestones and timelines will be achieved. Perform all required activities to ensure appropriate monitoring of investigator sites and study execution under the supervision the Manager Clinical Field Operation The SCRA is responsible for the management of day-to-day aspects of study sites for the assigned projects and provides updates to the study team Minimum of 4 — 5 years field monitoring experience.

Under the direction of the study manager, coordinate investigational device inventory and accountability. Knowledge of GCP-ICH and International regulatory requirements governing medical device research and development Prior experience coordinating industry sponsored clinical studies. Assume ambassadorial role to facilitate communication between sites and Novartis line functions and increase value proposition to investigators Facilitate preparation and collection of site level documents; resolve problems as required Execute site initiation and training Implement total site management including monitoring visits, regulatory assessment, drug supply management and resolution of site problems to ensure compliance Track trial execution milestones; identify problems; resolve issues and escalate as appropriate Manage recruitment and execute contingency plans, as needed.

Minimum of two 2 years of clinical research monitoring experience including pre-study, initiation, routine monitoring and closeout visits Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines Fluent in local office language and in English, both written and verbal. Have a full understanding of Serious Adverse Event SAE reporting, process production of reports, narratives and follow up of SAEs Excellent registry administration skills Good planning and organization skills Good computer skills with good working knowledge of a range of computer packages.

Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor Interact with internal work groups to evaluate needs, resources and timelines Assist with training, mentoring, and development of junior employees, e. Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned Minimum of Four 4 years of clinical research monitoring experience including pre-study, initiation, routine monitoring and closeout visits Have a full understanding of the Serious Adverse Event SAE reporting, process production of reports, narratives and follow up of SAEs.

Assisting with training, mentoring, and development of new employees, e. Minimum 2 years of monitoring experience including pre-study, initiation, routine monitoring and closeout visits - oncology experience highly preferred Oncology experience is a definite plus Fluent in English and local language, both written and verbal. Monitoring skill, site management skill, communication skills Good planning and organization skill, computer skills Ability to resolve project related problems and priorities workload and work in a team.

All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits Degree educated Life Science Few years of relevant clinical research experience in pharmaceutical or CRO industries Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countries Full understanding of Serious Adverse Event SAE reporting, process production of reports, narratives and follow up of SAEs Fluent Norwegian and English language skills.

Ideally minimum of 2 years of clinical research monitoring experience including pre-study, initiation, routine monitoring and closeout visits at a CRO or Pharmaceutical environment Fluency in German and English.

The clinical research associate will be responsible for ensuring that the sites used for clinical studies meet ICH GCP requirements CRAs will visit clinical trial sites for pre-qualification, site initiation, interim monitoring and site closeout The CRAs are also responsible for documenting study visits, and participate in study planning and coordination Bachelor's Degree required, certification as a CRA or clinical research professional highly desired Experience monitoring sites for human clinical trials, site initiation, monitoring, and closeouts desired Attention to detail is critical as well as excellent oral and written communication.

Search Jobs US. Undertake feasibility work when requested Minimum 2 years of relevant clinical research experience in pharmaceutical or CRO industries Knowledge of Hungarian, Romanian and English languages is a must Contract negotiation experience Understanding of the clinical trial process. Ensures adequate documentation and proper implementation of written protocols Serves as a liaison between Align Technology and the study site, investigators, study coordinators, staff members Provides technical assistance to study sites regarding the conduct of clinical research Oversees delivery and shipment of aligners for clinical studies Follows all departmental and company procedures as indicated in quality, administrative, or other systems Comply with all safety policies, practices and procedures.

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors, responsible for all aspects of site management and registry management as prescribed in the project plans Organize and make presentations at Investigator Meetings Preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned.

May assist with, and attend, Investigator Meetings for assigned studies May serve as mentor for new clinical study monitors Attend study-related, company, departmental, and external meetings, as required Conduct Field Evaluation Visits and field training of CRA Is, IIs and Sr CRAs Working knowledge of all functional areas of clinical trials and medical terminology.

Take charge of all aspects of Site Management as prescribed in the project plans Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned Ability to monitor study sites independently according to protocol monitoring guidelines, S.

Conducts all types of clinical monitoring visits i. Assist with management of third party vendors Monitor and manage study sites, as necessary Track and prepare study- specific information utilizing databases, spreadsheet and other tools Assist in the development, assembly and distribution of study documents, manuals and tools Reporting of study issues to Sr.

A minimum of 5 years experience in the pharmaceutical industry, with minimum 3 years direct experience in monitoring and managing study sites The candidate should have significant experience with responsible roles in the conduct or management of Phase I — III clinical trials The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an.

Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visit; liaise with vendors; and other duties, as assigned Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of data submitted on Case report Form CRFs or other data collection tools by careful source document review.

Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor.

Monitoring of moderately complex clinical experimentation including data collection, summary and thorough analysis, in support of department research projects and guidelines.

Compose robust experimentation strategies that maximize effective use of resources and time to deliver optimum information Apply knowledge of FDA regulations to site monitoring and clinical study design duties Apply knowledge of Alere products to effectively train clinical sites before study initiation Generate oral and written reports as necessary and to summarize clinical investigations and projects.

Play a major role in the formulation of research strategies and tactics Interact with study coordinators at clinical sites to ensure optimal study progression and resolve problems.

Pro-actively recommend strategies to overcome hurdles May functionally direct junior staff as required Initiate literature review and searches to support ongoing research activities. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Writes visit reports and uploads into eTMF within 5 working days for review and approval. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Uses study tools and management reports available to analyze trial progress Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams May submit requests for vendor services and may support vendor selection May lead negotiation of trial site contracts and budgets.

Develops strong therapeutic knowledge to support roles and responsibilities.