Clinical Trials Management Associate - Santa Monica, United States - STEM

STEM

Verified Company

Santa Monica, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Position:
Clinical Trials Management Associate - I

Location:
Santa Monica, CA, 90404

Duration: 6 Months

Job Type:
Contract

Work Type:
Onsite

Description:

Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas.
Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
Monitors fairly 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.
Under supervision 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. May resolve routine monitoring issues.
Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
Travel is required.
Excellent verbal, written, interpersonal and presentation skills are required.
Must be familiar with routine medical/scientific terminology. Must be familiar with Word, PowerPoint, and Excel.
Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable. Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
Must be able to contribute to SOP development.