
Manager Clinical III
Required skills
- clinical research
- ICH-GCP
- NCI regulations
- FDA regulations
- MS Office
- databases
- Internet
- communication skills
- patients
- operational issues
Nice to have
- CCRP
- CCRC
Role summary
The Phase 1 Clinical Trial Manager (CTM) will support the expansion of research operations for the Early Phase Therapeutics program. This role involves overseeing daily operations for solid tumor focused Phase 1 trials, acting as the main liaison between investigators, research staff, ancillary departments, and sponsors. Responsibilities include managing research billing, ensuring compliance, and monitoring portfolio performance through data metrics. The position requires a Bachelor's degree, 3-5 years of clinical research experience, and proficiency with computers and communication. Preferred qualifications include a Master's degree and relevant certifications.
City/State:
Bronx, New YorkGrant Funded:
YesDepartment:
Cancer Clinical Trials Office - Operations-Early PhaseWork Shift:
DayWork Days:
MON-FRIScheduled Hours:
9 AM-5:30 PMScheduled Daily Hours:
7.5 HOURSPay Range:
$76,000.00-$95,000.00The Phase 1 Clinical Trial Manager (CTM) will assist the CCTO Phase 1 Program Director and the Medical Director of the Early Phase Therapeutics program in expanding research operations. The CTM will oversee and coordinate daily operations of the solid tumor focused Phase 1 trials and serve as the primary point of coordination between investigators, research staff, ancillary departments, and sponsors. The CTM will handle research billing tasks and is responsible for ensuring research billing compliance, and will review data metrics to monitor portfolio performance. The portfolio includes studies sponsored by pharmaceutical companies, federal grants, and investigator-initiated protocols. Other duties as assigned.
Requirements
- Bachelor's degree required, Master's degree preferred
- 3-5 years experience in clinical research
- CCRP (SOCRA) or CCRC certification preferred
- Knowledge of ICH-GCP and NCI and FDA regulations regarding clinical trials
- Proficiency with computers (e.g., MS Office, databases, Internet)
- Excellent communication skills, with a demonstrated ability to build effective working relationships with investigators, cross-functional teams, and patients
- Proactive approach to anticipating, resolving, and escalating operational issues
- Well organized and detail oriented
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