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.