What are the responsibilities and job description for the Clinical Trials Management Associate position at Fladger Associates?
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.
