"Senior Clinical Research Manager"

Senior Clinical Research Manager

The Childhood Research Obesity Prevention Lab under the Department of Pediatrics, Division of Gastroenterology, Hepatology, and Nutrition (Pediatric GI) within Stanford University is seeking a Senior Clinical Research Manager to provide leadership and oversight of complex large or multiple small clinical research projects. Supervise multiple clinical research staff, leads, managers. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. Mentor Clinical Research Managers.

The selected candidate must have the ability to implement, organize and perform oversights of all aspects of complex, multi-site, multi-level clinical studies combined with knowledge of good clinical practice (GCP) and health care economics including insurance billing, research-related financial and budgetary processes (tracking study costs and sponsor payments). S/he will lead the team of clinical research managers and clinical research coordinators in conducting the research studies in all aspects of clinical and translational research studies including regulatory compliance, study implementation, protocol development, data management, teaching and training of clinical staff, and maintaining research databases that are used to promote high quality care and improve performance in the clinical care of patients. Previous clinical research management experience is required. Previous clinical trial experience at Stanford and/or LPCH is highly desirable. Previous experience with health services research methods to conduct patient-centered, community-based clinical trials using quantitative, qualitative, and implementation science methods is preferred.

Duties include:

• Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials in patient-centered and community-based partnerships. Monitor staffing levels and identify adequate coverage for workload across teams of study coordinators.
• Supervise development, implementation, and adherence in relation to study protocols and operating procedures. Educate research staff on established policies, processes, and procedures.
• Oversee and monitor strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Oversee development of consent forms for approval by Human Subjects Panel for investigator-initiated multi-site clinical research trials including behavioral and social needs interventions in partnership with patients, clinical sites, and community organizations.
• 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.

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

Pay Range: $139,909.00 to $165,398.00 annually (California Bay area).

DESIRED QUALIFICATIONS:

• Excellent oral and written communication skills
• Exceptional attention to detail
• Experience with pediatric behavioral, nutrition, and/or community-based participatory research
• Experience with managing multi-site randomized clinical trials
• Experience training, mentoring, and supervising others on topics related to clinical research conduct, management, and regulatory requirements
• Experience auditing clinical research projects
• Training and experience in project management approaches

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.
• Excellent diplomacy skills
• Proficiency in Microsoft Office and database applications, and EHRs (i.e., REDCap Cloud, EPIC).
• 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.
• Minimum of three years of demonstrated managerial experience.
• Demonstrated disease knowledge / study design experience of studies under purview.

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.

WORKING CONDITIONS:

• May be exposed to blood borne pathogens.
• May be required to work non-standard, extended or weekend hours in support of research or project work.