What are the responsibilities and job description for the Clinical Trial Management Associate - II position at Careers Integrated Resources Inc?
Job Title: Clinical Trial Management Associate - II
Job Location: Santa Monica, CA
Job Duration: 6 Months (Possible Extension)
Pay Range: $48.40/hour. on W2
Job Description:
Job Location: Santa Monica, CA
Job Duration: 6 Months (Possible Extension)
Pay Range: $48.40/hour. on W2
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 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.
Salary : $48
