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.
Clinical Research Manager 2 – Thoracic Oncology - Hybrid Work Arrangement
The Stanford Cancer Institute’s Clinical Trials Office (SCI-CTO) is the centralized organization for cancer clinical research operations at Stanford Medicine. The SCI-CTO, with over 200 staff, provides high quality and efficient services supporting the development, activation, and completion of scientifically impactful cancer clinical trials serving the SCI’s catchment area.
The SCI earned its most recent comprehensive cancer center designation by the NCI in 2022, and is a prominent, growing and complex Institute within Stanford Medicine. Cancer clinical research is integrated throughout Stanford Medicine which is comprised of Stanford School of Medicine and our adult and pediatric health systems – Stanford Health Care and Stanford Children’s Health. The SCI actively works to build synergies and collaborations across Stanford Medicine.
Given the SCI’s mission, breadth, and depth, we thrive in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. You will be working with a leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena. The SCI and its leaders are committed to demonstrating cultural awareness and diversity, equity, and inclusion.
Reporting to an Associate Director of Clinical Research, the Clinical Research Manager2 (CRM2) will provide oversight, guidance, and support for the conduct of cancer clinical research to the Thoracic oncology and any other assigned Clinical Research Groups (CRG(s). The CRM2 will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to conduct impactful clinical research with a focus on high quality and efficiency.
We are seeking candidates with excellent organizational skills, attention to details and excellent clinical research knowledge. Candidates must be eager to take on challenges with a high degree of professionalism, initiative and flexibility.
This position collaborates closely with physician investigators and clinical research staff to drive successful implementation of cancer clinical trials. Responsibilities include working with the research team(s), clinical staff and Stanford Health Care departments to support conduct of safe and compliant clinical research.
DESIRED QUALIFICATIONS:
7 years of direct clinical research experience, or an equivalent combination of education and relevant experience.
Management experience required.
Master’s degree preferred.
Oncology experience preferred.
Experience in a hospital and/or clinic setting 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.
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.
Additional Duties Include*:
Oversee, guide, and mentor the conduct of clinical research for the Thoracic oncology CRG and any other assigned CRG.
Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials.
Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
Audit operations, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes.
Monitor processes/workflows to ensure best practices and efficiencies.
Provide leadership and expertise in identifying and supporting CRG goals, including strategies to support growth and clinical trial accruals.
Manage and track research program financial status through development of detailed reports for discussion with research leaders.
*-Other duties as assigned.
Qualifications
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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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