Clinical Research Study Start Up Manager

Clinical Research Study Start Up ManagerPosition: Clinical Research Start-Up Manager – HybridJob 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 TrialsWill require Site Visits across 5-6 Sites in and around the Brooklyn areaSupport Principal Investigator at the siteDebrief Principal InvestigatorTrain Sites:FeasibilityStart-UpPatient RecruitingEDCFollow-UpClose-OutQuery resolutionIRB SubmissionsAE/SAE reportingJOB QUALIFICATIONS: Minimum requirements to be considered qualified to do the job. Required Minimum Education: Bachelor’s Degree5 years of clinical research experience including Start-Up and Site Management25% Travel: Brooklyn, Rockland, and WestchesterRegulatory background and experiencePatient RecruitingExperience working with IRBEDC experienceMinimum Certification: GCP CertificationMinimum 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. 9444359 New York, NY, US Scientific Bachelors Degree Full Time, Temporary Experienced (Non-Manager) Remote Biotechnology/Pharmaceuticals First Shift (Day)