Clinical Trial Management Associate
Proclinical is currently recruiting for a Clinical Trial Management Associate with a pharmaceutical company located in San Mateo, CA.
- With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
- Assures site compliance with the routine protocol and regulatory requirements and quality of data.
- Assists in the setting and updating of study timelines.
- Assists in CRO or vendor selection.
- With guidance from supervisor coordinates CROs or vendors.
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations and manuscript development.
- Interfaces with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
- Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives. T
- ravel is required.
Skills and Requirements:
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word,
- PowerPoint and Excel.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
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.