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Clinical Research Associate (Other)
Recruited by: Bharathi Nekkanti | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Other
  • Compensation: to be determined
  • Expires: Jan 29, 2020
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Job Description

Job Summary

DOCS clients include small, mid and large sized Pharmaceutical companies in addition to many leading Biotechnology, Medical Device companies and CROs. As a global partner, DOCS currently offers global resourcing solutions to our clients.

Roles & Responsibilities of the position


- Under the supervision of project lead or clinical study manager, help facilitate information flow between all members of the clinical operations/clinical trial site team, including in-house departments, clinical project team members, external CRO or contracted members, vendors, and other personnel as appropriate.
- Support coordination of day-to-day activities of clinical trials.
- May help create/track detailed project plans for assigned clinical trials.
- Prepares and facilitates the review of case report forms, protocols, investigator's brochures, instructions for use, study operations manuals, site and FDA annual reports.
- Develops and maintains relationships with outside consultants and vendors as required for each protocol.
- Reviews study budgets within the established guidelines, provides initial review of study contracts for changes in consultation with the project lead or clinical study manager.
- May participate in the identification, evaluation and selection of clinical investigators.
- May train and mentor less experienced CRAs, CTAs and new team members (as applicable).
- Perform monitoring visits to regional clinical sites or at problem sites (as required).
- Interfaces externally with clinical investigators, investigational sites and project vendors
- Receive, review, track/inventory and filed all documents pertaining to applicable clinical research studies.
- Prepare, maintain, and return/archive project master files as applicable.
- Perform project master file reviews as outlined in project specific plan.
- Request, manage, distribute and track study supplies.
- Update and maintain study-specific trackers and systems under direction of Project Lead.
- Coordinate, provide set up, and attend project meetings including: internal, CRA, client meetings and presentations.
- Assist with distribution of documents.
- Assist in identifying and implementing best practices and continuous improvemen

Job Requirements

- CRA with strong monitoring experience.
- CRAs with Site Monitoring experience. -
Medical Device experience is preferred, but not required.
- Prefers candidates who have experience working at Sponsors rather than sites.