Oversight Clinical Research Associate job in San Diego, USA

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Job type: Permanent

Discipline: Clinical Trial Assistant (CTA), Clinical Research Associate (CRA), Clinical Outsourcing

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Senior Oversight Clinical Research Associate (OCRA) for a complex disease Biotech company located in Stamford, CT. Senior Oversight CRA will oversee the performance of the CRO CRAs and may also co-monitor and/or conduct independent monitoring visit. The Oversight CRA will also help with various aspects of the clinical trial process as needed.

Job Responsibilities:

Conduct oversight visits to assess CRO CRA and Investigational Site performance
Have knowledge and use ICH/GCP guidelines, Investigator's Brochure
Write oversight visit reports, providing feedback on identifies issues
Follow-up on identified issues by conducting additional oversight visits as needed
Train/Re-train CRO CRA's and/or sites as needed
Assist in the creation/revision of study documents including ICFs, clinical monitoring plans, templates, etc.
Create training materials, conduct team trainings and/or review reports, spreadsheets and data listings with a keen eye for details
Conduct pre-study visits, initiation visits, monitoring visits and/or close-out visits

Skills and Requirements:

4-5+ years of experience as a Clinical Research Associate
Therapeutic and/or clinical experience in chronic kidney disease and dialysis preferred
Therapeutic and/or clinical experience in patient reported outcome, liver disease, and/or dermatological condition would be an advantage
Ability to travel 50-75% ~ 6 days onsite a month (West Coast)
Detail-oriented with strong communication skills
Ability to work across multiple trials and multiple therapeutic indication

If you are having difficulty in applying or if you have any questions, please contact PJ Kaur at (+1) 347-293-2524 or p.kaur@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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