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Senior Clinical Research Program Manager
2 months ago
Northwell Health is seeking a highly skilled Senior Clinical Research Program Manager to join our team. As a key member of our research administration team, you will be responsible for managing research administration at clinical sites, ensuring the quality and accuracy of clinical trial data, and following established monitoring Standard Operating Procedures (SOP) and protocol-specific monitoring plans.
Key Responsibilities:- Train, coach, and support Site Clinical Research Managers and other team members.
- Manage clinical research sites, including acting as primary contact for clinical research sites for questions related to protocol conduct, regulatory document completion, study supplies, client scheduling, and electronic data capture.
- Provide on-site or remote monitoring of clinical research site activities to ensure compliance with protocols, SOPs, and relevant federal and state regulatory and institutional policies.
- Consult on study start-up activities regarding development of study protocol, SOP, or Case Report Forms (CRFs), site qualification, data collection, and study conduct.
- Participate in site initiations and trainings.
- Assess accuracy, completeness, and timeliness of study records by performing source data verification, regulatory document and consent form review, adverse event reporting compliance review, and investigational product accountability.
- Perform study close-out monitoring activities.
- Provide pre-review assistance prior to regulatory inspections and submissions.
- Provide guidance on regulatory submissions to the FDA, including Investigational New Drug (IND), Investigational Device Exemption (IDE), New Drug Application (NDA), or other research under the purview of the FDA.
- Prepare and forward monitoring reports to program manager, working with study staff to address any concerns.
- Promote overall compliance and quality with research conduct through participation in education and training activities for professional staff.
- Assist in developing appropriate education and training sessions for investigators and clinicians involved in research.
- Work on assignments that involve moderately complex to complex issues where the analysis of situations or data requires in-depth evaluation of variable factors.
- Regularly make new recommendations on new processes, tools, and services that can impact multiple projects and other functions.
- May provide technical guidance and direction to support team members, contractors, and/or other vendors.
- May serve as project/technical lead for ongoing processes or short-term projects within function or family.
- Perform related duties as required.
- Bachelor's Degree or equivalent combination of education/related experience, required.
- 3-5 years relevant experience, required.
- Experience with clinical trials, preferred.
Northwell Health is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to providing a work environment that is free from discrimination and harassment. If you are interested in this opportunity, please submit your application through our website.
