Clinical Project Associate
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.
- 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.