Sr. Clinical Research Program 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.

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, 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.

Available to work fully on-site 5 days a week.

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

• 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.

Benefits that support you, and your future

18+ PTO days per year

Health benefits start when you start

Flexible work options

$6000+ annual tuition and training assistance

403(b) plan

Mental health and wellness programs

Free and discounted commuter transportation

Applies to regular full-time positions.

Notice to Applicants

The job duties listed are typical examples of work performed by positions in this job classifications and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

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 their job.

Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected under law.

Stanford University provides job pay ranges representing its good faith estimate of what the university reasonably expects to pay for a particular job. The specific pay offered to a selected candidate will be determined based on a wide range of factors that are unique to each candidate, including but not limited to geographic work location, relevant knowledge, skills and abilities, relevant education, years of relevant experience, depth and breadth of relevant experience, and performance; further including but not limited to other business and organization needs such as the scope and responsibilities of the position, the minimum qualifications, departmental budget availability, and market and internal equity across the university, school/ unit, department, as well as job reporting relationships.

Why work at Stanford

World-changing work in a culture of continuous learning

An inspiring community that values collaboration

High-quality health and wellness benefits that put you and your family first

Access to world-class education and career development, with tuition reimbursement, training assistance, and more