What are the responsibilities and job description for the Clinical Trials Management Associate position at The Fountain Group?
Details for the position are as follows :
6-month contract to start with the possibility of extension or conversion depending on performance and budget.
Rate : $45-50 an hour
Location : Santa Monica, CA – 100% onsite
Job Description :
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
Required Skills :
Bachelor’s degree required.
Experience with the following 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.
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