Clinical Trials Management Associate - I

We are seeking a talented and experienced individual to fill the role of Clinical Trials Management Associate - I, based in Foster City, CA.

Responsibilities

• Provide administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
• Monitor routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• May assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
• May assist in compilation of investigator brochures under close supervision.
• Assist in preparation of safety, interim and final study reports.
• Participate in departmental or interdepartmental strategic initiative.
• Contribute to SOP development.

Skills And Qualifications

• Must be familiar with routine medical/scientific terminology.
• Strong knowledge of Microsoft Office Suite.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
• Excellent written and verbal communication skills,
• Travel is required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Christopher Frank at (+1) 2674056996 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

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