Clinical Project Associate

Highly Competitive Salary
  1. Permanent
  2. Clinical Research Associate (CRA), Clinical Scientist
  3. United States
San Mateo, USA
Posting date: 28 Jul 2020
CR.CN.30888

Proclinical is currently recruiting for a Clinical Project Associate with a pharmaceutical company located in San Mateo, CA. A successful candidate will have at least 1 year of clinical experience, TMF/eTMF (Trial Master File) experience, and has knowledge of GCPs and ICH guidelines.

Job Responsibilities:

  • Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
  • Reviews and participates in the quality assurance of study documents or data.
  • Assists with the development of study documents, forms or contents for study site binders.
  • Processes drug return forms, order clinical trial supplies (such as Mini Protocols, PRO worksheets, drug return shipment labels).
  • Completes eTMF filing following the filing structure.
  • Completed reconciliation of eTMF filing.
  • Manage administrative tasks to manage study activities.
  • Arranges meeting logistics.
  • Assists with drafting meeting agendas/minutes, handles distribution to team.
  • Interacts with other departments, as directed, to complete assigned tasks.
  • May assist with monitoring visits report reviews or data line listing reviews under the direct supervision of senior staff.
  • Travel may be required.

Skills and Requirements:

  • At least 1 year of clinical experience, TMF/eTMF (Trial Master File) experience, and has knowledge of GCPs and ICH guidelines.
  • Excellent verbal and written communication skills and interpersonal skills are required.
  • Must be familiar with Word, PowerPoint, and Excel. Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus. Must be able to work both independently and as part of a team.

If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.

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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