Position: Clinical Research Start-Up Manager - Hybrid Job description: The Clinical Research Start-Up Manager is an experience clinical trial research professional with research-specific knowledge and skills, who has general responsibility for managing clinical trials for the Research System . The Clinical Trial Start-Up Manager will train 5 to 6 local sites that are new to clinical trials. The training will work toward providing the sites guidance to be able to conduct their trials independentl... more details
Clinical Research Study Start Up Manager
Position: Clinical Research Start-Up Manager – Hybrid
Job description: The Clinical Research Start-Up Manager is an experience clinical trial research professional with research-specific knowledge and skills, who has general responsibility for managing clinical trials for the Research System . The Clinical Trial Start-Up Manager will train 5 to 6 local sites that are new to clinical trials. The training will work toward providing the sites guidance to be able to conduct their trials independently from start-up through follow-up and close-out. ******ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board IRB requirements, and WRI policies and procedures. Utilizing the nursing process, the RN Research Coordinator is primarily responsible for coordinating clinical trials in a manner that holds the protection of human subjects as the most important principle.
Role and responsibilities:
Area of focus: Asthma Clinical Trials
Will require Site Visits across 5-6 Sites in and around the Brooklyn area
Support Principal Investigator at the site
Debrief Principal Investigator
Train Sites:
Feasibility
Start-Up
Patient Recruiting
EDC
Follow-Up
Close-Out
Query resolution
IRB Submissions
AE/SAE reporting
JOB QUALIFICATIONS:
Minimum requirements to be considered qualified to do the job.
Required Minimum Education: Bachelor’s Degree
5 years of clinical research experience including Start-Up and Site Management
25% Travel: Brooklyn, Rockland, and Westchester
Regulatory background and experience
Patient Recruiting
Experience working with IRB
EDC experience
Minimum Certification:
GCP Certification
Minimum Skills:
Strong computer skills; good oral and written communication skills; excellent interpersonal and organization skills.
Possess excellent time management skills
If you have 5 years of Clinical Research Experience including Lead Clinical Research Coordinator and Site Manager and reside in the Brooklyn Area – APPLY TODAY!
Kelly Science & Clinical® is working with a growing clinical research network based out of Brooklyn, New York with an immediate need for a Clinical Research Start Up Manager for their clinical trials.
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