Clinical Research Supervising Lead

17 hours ago

Palo Alto CA United States Stanford University Full time

Clinical Research Supervising Lead – Hybrid – Neurology/Surgical research group

The Stanford Cancer Institute (SCI) is one of an elite number of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Clinical Research Supervising Lead (CRC3) to help us enact our mission to reduce cancer mortality through comprehensive cancer research, treatment, education and outreach. Given the SCI's mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CTO) is an integral component of the Stanford Cancer Institute. The vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading-edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.

Reporting to the Neuro Clinical Research Manager (CRM), the CRC3 will be conversant in the goals, mission, and priorities of the Institute, and utilize this knowledge to ensure the safety and well-being of trial participants. We are seeking candidates with excellent interpersonal skills and attention to detail. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. This position is based on the Stanford Medicine campus with options for hybrid work.
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 and manage all aspects of clinical trials including industry and investigator-initiated trials.
  • Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
  • Manage data/oversee data management for research projects. Meet DSMC requirements for site management up to date. Develop and manage systems to organize, collect, report, and monitor data collection. Extract and analyze data.
  • Maintain site regulatory file, per CTO guidelines.
  • Develop project schedules, keep targets, measurements, and accountabilities, as assigned. Lead team and clinic operations meetings and prepare/approve minutes.
  • Formally mentor new staff, as assigned, participate in hiring process, prepare or assist with the preparation of performance evaluations and performing related duties, in addition to instruction on project work.
  • Audit operations to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board/SRC/DSMC submissions, and respond to requests and questions.
  • Collaborate with principal investigators, monitor and report serious adverse events, and resolve study queries.
  • Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
  • Develop study budget with staff and principal investigator, track patient and study specific milestones, review patient billing and invoice sponsors according to study contract.
  • Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance. Manage audit preparation of clinical trials at Stanford and subsites. Provide oversight to subsites.
  • Work with principal and clinic lead investigators to ensure Institutional Review Board renewals are completed.

DESIRED QUALIFICATIONS:

  • Neurology and Surgical trial coordination.
  • Oncology trial coordination.
  • Hospital/clinic site coordination.

EDUCATION & EXPERIENCE (REQUIRED):

Bachelor's degree in a related field and four years of experience in clinical research, or an equivalent combination of education and relevant experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Excellent interpersonal skills.
  • Proficiency in Microsoft Office and database applications.
  • 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.
  • Demonstrated project/program leadership skills.
  • 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.

* - 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.
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