Associate Clinical Research Associate

Job Description With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites.

1. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
2. Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
3. Gains an in-depth understanding of the study protocol and related procedures.
4. Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
5. Participates & provides inputs on site selection and validation activities.
6. Performs remote and on-site monitoring & oversight activities using various tools to ensure:
1. Data generated at site are complete, accurate and unbiased.
2. Subjects’ right, safety and well-being are protected.
7. Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
8. Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
9. Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
10. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
11. Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
12. Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
13. Supports audit/inspection activities as needed.
14. Performs co-monitoring where appropriate.