Inside Higher Ed · 1 month ago
Clinical Research Manager (6-Month Fixed-Term) (Hybrid Opportunity)
Stanford, CA
Full-time
Hybrid
Mid, Senior Level
$125K/yr - $154K/yr
5+ years expStanford University is seeking an experienced and collaborative Clinical Research Manager to join their expanding clinical research program in the Division of Pulmonary, Allergy, and Critical Care Medicine. The role involves providing leadership and oversight of multiple clinical research projects, including staff supervision and management of clinical research operations.
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Responsibilities
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators
Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures
Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel
Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required
Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions
Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group
Lead or chair committees or task forces to address and resolve significant issues
Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences
Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance
Assist with analysis of data and preparation of manuscripts and scientific presentations
Qualification
Required
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience
Excellent interpersonal skills
Proficiency in Microsoft Office and database applications
Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices
Knowledge of medical terminology
Demonstrated managerial experience
Preferred
Master's degree preferred
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
Benefits
Career development programs
Tuition reimbursement
Superb retirement plans
Generous time-off
Family care resources
Health care benefits
Free commuter programs
Ridesharing incentives
Discounts
Company
Inside Higher Ed
Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-10Acquired
2006-08-31Series Unknown
Leadership Team
Stephanie Shweiki
Director, Foundation Partnerships
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