Clinical Research Manager 1

The Department of Medicine (DoM) Clinical Research Hub (CRH) at Stanford University, in collaboration with the Division of Blood and Marrow Transplant (BMT), is seeking an onsite Clinical Research Manager 1 (CRM) to provide leadership and oversight of the clinical research study portfolio for the Auto-immune Cell Therapy (ACT) program. The ACT program focuses on stem cell transplantation and cell immunotherapy. This program is a collaboration between the Division of Blood and Marrow Transplantation (BMT) and Cellular Therapy in DoM with other divisions and departments at the School of Medicine. These multi-disciplinary collaborations across many departments and divisions create a challenging and rewarding opportunity to engage in Sponsor-Investigator, industry sponsored, and federally sponsored first-in-human research. This portfolio will include observational, interventional and registry studies, both industry-sponsored and investigator-initiated, that span a multidisciplinary therapeutic area including and not limited to BMT, Neurology, Dermatology, Nephrology, and Hematology. The CRM will be responsible for establishing best practices, pre-award and study start-up, monitoring project timelines and progress, troubleshooting barriers including recruitment, retention and regulatory support to ensure GCP compliance and participant safety.

This position will be in a key leadership role, interfacing with leadership, faculty and collaborators within the ACT program, DoM, SoM and SHC as well as external partners, sponsors and collaborators. This position will supervise multiple clinical research staff, and be responsible for their hiring, onboarding, training, mentorship, coaching and ongoing performance management. This position will be responsible for the overall oversight of the management of clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight. The ideal candidate for this role must be very experienced in both regulatory and operational knowledge needed for the conduct of observational and interventional drug, biologics and device research, display agility and flexibility in a dynamic environment, provide compassionate participant experience and have prior direct experience managing teams. Exceptional diplomacy, outstanding interpersonal and clear, proactive communication skills, leadership, ability to work independently and without significant oversight, with integrity, attention to detail, and the ability to proactively manage challenges are essential qualities desired in a successful candidate.

Core Duties:

• Hire, orient, train, and conduct performance reviews for staffhandling research administration activities associated with theconducting of clinical trials. Monitor staffing levels and identifyadequate coverage for trial workload across teams of studycoordinators.

• Supervise the implementation of and adherence to study protocols.Educate research staff on established policies, processes, andprocedures.

• Determine effective strategies for promoting/recruiting researchparticipants and retaining participants in long-term clinical trials.Develop consent forms for approval by Human Subjects Panel.

• Coordinate new protocol submissions, renewals, and revisions toInstitutional Review Board for multiple studies. Complete annual reportsto Institutional Review Board, CSTA, FDA and other regulatory agencies.Submit Investigational New Drug applications to the FDA asrequired.

• Audit operations, including laboratory procedures, to ensurecompliance with applicable regulations; provide leadership inidentifying and implementing corrective actions/processes. MonitorInstitutional Review Board submissions and respond to requests andquestions.

• Provide leadership and expertise in identifying and completingresearch grants. Oversee financial resources, as needed, create internaland external budgets for research protocols, assure financialaccountability, and serve as primary liaison between sponsor, departmentaccounting, and Research Management Group.

• May lead or chair committees or task forces to address andresolve significant issues resulting from research activities.

• Engage in high-level outreach and networking opportunities,representing the research program to a variety of internal and externalaudiences.

• Analyze trends in recruitment and ensure there is a limitednumber of competing trials. Make recommendations for a variety ofoptions within a trial; track physician compliance.

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

Minimum Education:

Bachelor’s degree in related field

Minimum Experience:

Five years of experience in clinical research, or an equivalentcombination of education and relevant experience. Master's degreepreferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal skills.

• Excellent diplomacy skills.

• Proficiency in Microsoft Office and databaseapplications.

• Experience with research protocols and regulatory or governingbodies, which include HIPAA and FDA regulations, Institutional ReviewBoard requirements, and Good Clinical Practices.

• Knowledge of medical terminology.

• Demonstrated managerial experience.

• Demonstrated disease knowledge / study design experience ofstudies under purview.

Certificates and Licenses Required

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