The Early Clinical Development Senior Clinical Research Associate will have relevant Phase I experience, responsible for conducting monitoring activities for one or more client sponsored studies.
The Sr. CRA functions as a member of the clinical study team and performs study monitoring according to Good Clinical Practices (GCP), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and client Standard Operating Procedures (SOPs).
- Performs site management activities to ensure compliance to the protocol, monitoring plan, GCP, ICH, applicable federal / local regulations, and SOPs
- Responsible for monitoring clinical trial quality and site management for client sponsored studies that are not fully outsourced to a contract research organization (CRO)
- Conducts site qualification, initiation, interim, and close-out visits
- Ensures sites meet performance expectations related to recruitment, enrollment, and retention
- Reviews site source documentation, case reports, and verifies accurate data capture
- Ensures site regulatory files are current, and verifies the timely submission of study documentation (including safety reporting)
- Performs drug accountability, reconciliation, and destruction. Verifies storage and shipment requirements are according to protocol
- Identifies and records protocol deviations
Site Management
- Maintains ongoing communications with site personnel and assists with problem solving during all stages of study start up, conduct, and close out
- Builds and maintains professional relationships with site personnel
- Analyzes issues and uses sound judgment to make decisions and escalates study related issues as necessary
- Travels to clinical study sites as required, including remote or onsite visits globally
Skills :
- Analytical problem-solving experience, trouble shooting and resourcefulness
- Working knowledge of clinical drug development process
- Effective communication, interpersonal skills, and the ability to build relationships
- Familiarity with medical and clinical trial terminology
- Proficient in written and spoken English required
- Proficient in local language, as applicable, preferred
- Proficiency in widely used technologies
- Ability to learn client applications
- Travel to be inclusive of regional, national and international as required
Knowledge and Experience :
Minimum of 5 years relevant industry experience
Education :
- Bachelor’s Degree or equivalent is required
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