Oncology Clinical Research Operations Supervisor

1 week ago

San Luis Obispo, California, United States Medasource Full time

Position: Oncology Clinical Research Site Supervisor (RN)

Company: Medasource

Job Overview: The Oncology Clinical Research Site Supervisor, under the guidance of the Division Manager of Clinical Research Operations (DMCR), is responsible for overseeing the research coordination team and providing support to Principal Investigators (PIs), clinical departments, and sponsors in the execution of clinical trials and research initiatives. This role entails leading the research site team in participant recruitment, adherence to protocols, data collection, regulatory compliance, and comprehensive project management. Additionally, this position involves staff training, quality assurance, and ensuring adherence to federal regulations and policies. Occasional travel and after-hours work may be necessary.

Key Responsibilities:

Research Operations (45%):

  • Direct the local team in the creation and execution of Standard Operating Procedures (SOPs).
  • Collaborate with PIs and the DMCR to oversee clinical research programs.
  • Manage team scheduling, trial execution, and regulatory adherence.
  • Assist in trial feasibility evaluations, initiation activities, and recruitment strategies.
  • Supervise and assess research coordination personnel.
  • Ensure the accurate completion and submission of all study documents and forms.

Quality Assurance/Performance Improvement (35%):

  • Guarantee protocol compliance, precise data collection, and billing accuracy.
  • Supervise the informed consent process and manage study-required procedures and tests.
  • Oversee the secure management of study medications and laboratory procedures.
  • Coordinate sponsor monitoring visits and audits, addressing issues promptly.
  • Act as the primary liaison among research participants, investigators, and sponsors.

General Duties (20%):

  • Ensure PI signatures on all necessary study documents.
  • Represent the site team in discussions with investigators and sponsors.
  • Adjust work hours to accommodate participant and project requirements.
  • Complete all mandatory training, certification, and compliance obligations.

Required Education & Experience:

  • Bachelor's degree in a science or health-related discipline is required.
  • Leadership experience: Minimum of 1 year supervising research personnel is preferred.
  • Research Coordination: At least 1 year as a Senior Research Coordinator is required.
  • Clinical Trials Experience: 7+ years coordinating clinical trials, including serving as the primary coordinator for drug or device trials.
  • Healthcare Interaction: 7+ years of patient interaction in a healthcare environment is required.
  • Research Protocols: Experience in implementing research protocols and clinical trial processes is required.
  • Regulatory Documentation: Familiarity with regulatory and IRB documentation is required.
  • Training Competencies: Proven ability to train staff/investigators on clinical trial processes is required.
  • Technical Skills: Experience with electronic data capture software is required; Clinical Trial Management Systems (CTMS) experience is preferred.
  • Lab Processing: Experience is required.

Required Licensure & Certifications:

  • Current RN license in the state of California.
  • BLS certification is required.
  • IATA and/or Safe-T-Pak certification for the shipment of lab specimens and/or dry ice.
  • Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) is required.
  • Current certificate of Human Subjects Protection and Good Clinical Practice training is required.

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