Clinical Trials Management Associate - I
Clinical Trials Management Associate - I
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job 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.
Employment Type
Remote
Company Industry
Key Skills
- Portfolio Management
- Wealth Management
- Financial Services
- Hybris
- Microsoft Word
- Banking
- Cash Management
- Data Management
- Microsoft Powerpoint
- Securities Law
- Microsoft Excel
- Internet Of Things
