Clinical Research Manager 2

StanfordStanford, CA, US

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Clinical Research Manager 2 (Hybrid)

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 the Director of Clinical Research, the Clinical Research Manager2 (CRM2) will provide oversight, guidance, and support for the conduct of cancer clinical research to the Radiation Oncology Clinical Research Group 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.

Duties include

Oversee, guide, and mentor the conduct of clinical research for the GI 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.
Provide oversight and guidance on compliance with local, federal and international regulations on clinical research conduct.

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.

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.

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.

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Clinical Research Manager • Stanford, CA, US