Senior Clinical Research Associate, Argentina, Biotech
hace 1 mes
We are seeking a highly skilled Senior Clinical Research Associate to join our team in Argentina. As a Senior Clinical Research Associate, you will be responsible for participating in the preparation and execution of Phase I-IV clinical trials, overseeing the progress of clinical investigations, and monitoring clinical trials in accordance with Good Clinical Practices and procedures set forth by IQVIA Biotech and sponsors.
Key Responsibilities- Participate in the investigator recruitment process, performing site evaluation visits of potential investigators and evaluating the capability of the site to successfully manage and conduct the clinical study.
- Collaborate with the ISS department to coordinate activities with the site in preparation for the initiation of the study, obtaining regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
- Perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and providing training on completion of the eCRF; monitoring activities and study close-out activities.
- Train site staff on the EDC system and verify site computer system.
- 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, performing validation of source documentation as required by sponsor, and preparing monitoring reports and letters per the timelines defined in IQVIA Biotech SOPs.
- Document accountability, stability, and storage conditions of clinical trial materials as required by sponsor, performing investigational product inventory, and ensuring return of unused materials to designated location or verifying 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, working with sites to resolve data queries.
- May review protocols, eCRFs, study manuals, and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
- Serve as primary contact between IQVIA Biotech and investigator, coordinating all correspondence, ensuring timely transmission of clinical data with the study site and technical reporting, as requested.
- 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 Biotech and/or study timelines; CTMS should always be current with the pertinent site updates/contacts.
- Ensure all study deliverables are completed per IQVIA Biotech and study timelines.
- 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.
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