From Stanford University's posting. “We” and “our” refer to the employer.
Clinical Research Coordinators (CRCs) support, conduct, coordinate or manage the clinical research studies or trials on human subjects. Principal and co-investigators provide the overall direction in a clinical study, but CRCs can have significant roles in clinical study activities.
The Department of Neurosurgery seeks an experienced Clinical Research Manager with combined medical and surgical background to lead and coordinate clinical research operations across medical and surgical specialties. This position will provide leadership and oversight of complex clinical research projects, supervise multiple clinical research staff, and manage all aspects of clinical research operations including quality management, personnel management, regulatory compliance, and fiscal oversight.
The successful candidate will work collaboratively with faculty investigators, clinical teams, and research staff to ensure the successful execution of diverse research portfolios spanning medical and surgical disciplines. This role requires expertise in both medical and surgical clinical environments, strong leadership abilities, and a commitment to maintaining the highest standards of research quality and regulatory compliance.
This is a full-time, benefits-eligible position offering competitive compensation and comprehensive benefits in an academic medical center setting with opportunities for professional growth and scholarly activity.
Due to the number of candidates, we kindly ask that all candidates apply through the Stanford Careers portal only. Please do not reach out to individuals to inquire about the position.
DESIRED QUALIFICATIONS:
Direct clinical experience in both medical settings (inpatient/outpatient units, specialty clinics) and surgical settings (OR, PACU, surgical units).
Master's degree in clinical research, public health, nursing, or related field.
Experience with NIH-funded research including grant preparation and progress reporting.
Publication record in peer-reviewed journals.
Experience with both medical device trials and pharmaceutical trials across multiple phases.
Familiarity with translational research initiatives bridging basic science and clinical applications.
Knowledge of comparative effectiveness research and implementation science methodologies.
Experience with patient-reported outcomes and quality of life assessments.
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.
WORK STANDARDS:
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Qualifications
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APPLICABLE. REMOVE IF NOT APPLICABLE]
Drivers License Requirements
Must possess and maintain a valid California non-commercial Class
C Driver's License.
Ability to drive day or night.
When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.
Responsibilities
Core Duties: Select, develop, and evaluate personnel to ensure efficient operations, including hiring, performance management, and related duties. Oversee staffing and overall resourcing for program(s) under purview. Mentor Clinical Research Managers.
Audit operations to ensure effective implementation of internal processes and quality program. Provide leadership in identifying and implementing corrective actions/processes. Lead inspections or audits.
Oversee development of effective participant recruitment and retention activities. Oversee development of regulatory documents, including consent forms, for studies.
Make strategic decisions regarding new and existing clinical research projects that may impact resourcing, quality, safety and/or compliance of program(s) under purview. Lead or chair committees or task forces to address and resolve significant issues.
Develop and/or implement research goals for a clinical trial(s)/ therapeutic program in collaboration with multiple faculty members and internal/external stakeholders.
Oversee regulatory management of programs and troubleshoot complex regulatory issues. Mentor and train managers and staff on how to resolve compliance issues and regulatory challenges across programs/organizations.
Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct. Lead process and quality improvement initiatives to ensure efficiency in implementation of new protocols.
Manage and track research program financial status with regular reports to research leaders. Oversee development of appropriate study budgets that meet the needs of the research program.
Engage in high-level outreach and networking opportunities in a program leadership capacity, representing the research program to a variety of internal and external audiences.
Analyze trends in recruitment across the portfolio, develop and monitor use of standardized reporting of key metrics. Develop ideas and implement improved processes and tools to ensure program success and compliance.
Contribute to analysis of data and preparation of manuscripts and scientific presentations.
Minimum Education: Bachelor's degree in related field
Minimum Experience: Five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
Knowledge, Skills and Abilities: 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.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical
Research Professionals certification is preferred.
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