Clinical Research Coordinator Oncology Job at Medasource, San Luis Obispo, CA

OVRjM0NGbW9BcHl4ZTRjamdBZWNpeVU4Nnc9PQ==
  • Medasource
  • San Luis Obispo, CA

Job Description

Position: Clinical Research Coordinator - Oncology Trials

Locations: San Luis Obispo, CA -OR- Santa Maria, CA (Openings in both locations)

Duration: 6-month Contract to Hire

Start: ASAP

Position Description:

The Clinical Research Coordinator (CRC) works with the Market Clinical Research Manager (MCRM) to support the planning, implementation and coordination of clinical trials and other research projects managed by the Research Institute. Duties may vary depending on the size and complexity to each study. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent assists with clinical trial or other research project coordination duties as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. Under the direction of the MCRM and/or Senior Clinical Research Coordinator, the incumbent helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as internal Health policy.

Responsibilities:

  • Coordinate and participate in site initiation and other sponsor-required training for all protocols.
  • Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
  • Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
  • Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
  • Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
  • Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
  • Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
  • With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols.
  • Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and internal Health policy.
  • Prepare, manage and submit all required any required study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or internally.
  • To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
  • Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
  • Attend investigator/coordinator meetings as required by study sponsors.
  • Serve as liaison between participants, physician investigators, sponsors of research, IRBs, research institute administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
  • Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.

Qualifications:

  • Minimum 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials.
  • Minimum 3 years of experience interacting with patients in a healthcare setting required.
  • Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
  • Experience in implementation of research protocols and clinical trials processes required.
  • Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
  • Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
  • Lab processing experience required, Phlebotomy certification preferred.
  • Bachelor’s degree in a science or health-related field or a combination of education and/or additional job-related experience in lieu of the degree, required.
  • Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
  • Current certificate of Human Subjects Protection and Good Clinical Practice training required.

Job Tags

Contract work, Immediate start,

Similar Jobs

Holaday-Parks, Inc.

MEP Project Engineer - Anchorage, AK Job at Holaday-Parks, Inc.

 ...on site. Project Engineers support multiple projects when required. Career Path: The Project Engineer position is an entry level position in the Construction Industry. Experienced Project Engineers may have the opportunity to move into Project Manager roles... 

EPM Scientific

Manager, Quality Assurance Job at EPM Scientific

 ...Title: Manager, Quality Assurance Location: Springfield, MO (On-site) Summary: The Quality Assurance Manager is responsible for oversight of conditions and activities in API manufacturing areas to ensure continual compliance with cGMP standards. This position... 

Tata Consultancy Services

Logistics Coordinator Job at Tata Consultancy Services

Daily Tasks (not limited to) Prioritize shipments based on critical/premium status. All critical/premium shipments will be executed first, regardless of mode. Air shipments prioritized based on priority: NFO Next flight out (Highest Priority Critical/Premium...

Rehab Without Walls® Neuro Rehabilitation

Occupational Therapist Job at Rehab Without Walls® Neuro Rehabilitation

 ...collaborative and passionate team of dynamic therapists Make a real impact in a rewarding...  ...: Minimum of a bachelors degree in Occupational Therapy from a college or university...  ...in the home, community, workplace, or school, Rehab Without Walls promotes greater health... 

Spencer Ogden

Training Coordinator Job at Spencer Ogden

Training CoordinatorAbout the jobNutrien is a leading provider of crop inputs and services, and our business results make a positive impact on the world. Our purpose, Feeding the Future , is the reason we come to work each day. We're guided by our culture of care and...