Clinical Research Manager Stanford University, School of Medicine

Clinical Research Manager

 

 School of Medicine, California, United States

 

Stanford University Department of Pediatrics is seeking a Clinical Research Manager to provide leadership and oversight of one large and multiple small clinical research projects within the Stanford-LPCH PANS (Pediatric Acute-onset Neuropsychiatric Syndromes) Program. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, fiscal oversight, and provide assistance to manuscript and grant preparation. 



Duties include:



• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with all the clinical research projects with the PANS program. Monitor staffing levels, and identify adequate coverage for trial workload. Assure efficient flow of protocol visits and tasks in the absence of the Medical Director when needed.


• Supervise the implementation of and adherence to administrative aspects in preparation for and during conduct of study protocols (preparation of CRF templates, kitting for phlebotomy, setting up procedures for collection of clinical specimens, etc.). 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.


• Supervise timely updates to ClinicalTrials.gov for all PANS studies.


• Supervise creation of clinical data management procedures for use with Medrio or sponsor-specified electronic databases.


• 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 budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.


• Serve as primary liason with CTRU staff and clinic staff for scheduling of participants, requesting resources, assuring nursing and phlebotomy support for studies and tracking expenses. Responsible for providing clinical data to project investigators. 


• Lead or chair committees or task forces to address and resolve clinical research issues within Stanford.


• Engage in high-level outreach and networking opportunities, representing the PANS 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 and CTRU compliance.


• Assist with analysis of data and preparation of manuscripts and scientific presentations. 



* - Other duties may also be assigned

 

DESIRED QUALIFICATIONS:

• Bachelor's degree in basic science or psychology preferred.
• Experience working in a research setting preferred.



EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred



KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
• 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. 



CERTIFICATIONS & LICENSES:

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.



PHYSICAL REQUIREMENTS*:



• Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. 


• Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.


• Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.



* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.



WORKING CONDITIONS:



• Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
• May require extended or unusual work hours based on research requirements and business needs.

 


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