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Senior Clinical Research Associate, Argentina, Biotech
hace 2 meses
We are seeking a highly skilled Senior Clinical Research Associate to join our team at IQVIA. As a Senior Clinical Research Associate, you will play a critical role in the preparation and execution of Phase I-IV clinical trials.
Key Responsibilities- Participate in the preparation and execution of Phase I-IV clinical trials.
- Oversee the progress of clinical investigations by conducting site evaluation, initiation, and interim close-out visits to sites.
- Monitor clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA and sponsors.
- Work closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
- May serve as Lead CRA and perform additional tasks such as participating in investigator recruitment, site evaluation, and study initiation activities.
- Assist in resolving any issues to ensure compliance with site file audits in conjunction with ISS.
- Assure adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits.
- Prepare monitoring reports and letters per the timelines defined in IQVIA SOPs by using approved IQVIA/sponsor templates and reports.
- Document accountability, stability, and storage conditions of clinical trial materials as required by sponsor.
- Perform investigational product inventory and ensure return of unused materials to designated location or verify destruction as required.
- Review the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site source verification.
- Work with sites to resolve data queries.
- May review protocols, eCRFs, monitoring reports, and follow-up letters, study manuals, and other related documents as requested by the CTM and/or PM.
- May serve as primary contact between IQVIA and investigator, coordinate all correspondence, and ensure timely transmission of clinical data with the study site and technical reporting as requested.
- Assist CTM and/or PM in review of project budgets, monitoring costs, potential overruns, and propose/implement cost-effective solutions.
- Assist the study management in identifying and generating changes in scope.
- Perform study close-out visits per the study-specific Clinical Monitoring Plan, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock, and resolution of outstanding action items.
- Authorized to request site audits due to data integrity concerns.
- Attend study-related, company, departmental, and external meetings as required.
- Ensure internal and study-related trainings are completed per IQVIA and/or study timelines; CTMS should always be current with pertinent site updates/contacts.
- Ensure all study deliverables are completed per IQVIA and study timelines.
- May conduct Field Evaluation Visits and field training of CRA Is, IIs, and Sr CRAs.
- Serve as mentor for junior CRAs and those new to the company and/or study.
- Perform other duties as requested.
- BS/BA/BSc (or equivalent) in one of the life sciences or healthcare background (RPh, RN, etc) and a minimum of four (4) years of monitoring/site management experience is required; or equivalent combination of education, training, and experience.
- Prior Clinical Research Organization (CRO) experience preferred.
- Prior project team leadership experience preferred.
- Working knowledge of budget management preferred.
- Must be able to travel domestically and internationally approximately 65%-85%.
- Valid driver's license.
- Computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint and use of a laptop computer.
