Non-Clinical – Clinical Research Coordinator (Varied)

at Docs United
Published September 13, 2022
Location California
Category Non-Clinical  
Job Type Temp  
Specialty Clinical Research Coordinator
Shift(s) Description Days 40hr Guarantee
Shift Type Varied
Expenses Covered Daily Stipend
Medical Malpractice Covered
Requirements BLS Certification, Active State License



  • Understanding of ethical principles, culture and values of medical research.
  • Critical thinking skills, decisive judgment and the ability to work with minimal supervision.
  • Demonstrated ability to work independently yet collaboratively with all members of the research community including physicians/principal investigators, research team members, IRBs, hospital and clinic personnel, and sponsors of research.
  • Demonstrated ability to perform all research coordination duties for multiple clinical trials simultaneously.
  • Knowledge base to provide education to patients, families, and other staff regarding clinical and patient care issues, including patients who may have a terminal disease.
  • Excellent interpersonal and communication skills, both verbal and written, required.
  • Highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.
  • Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
  • Ability to formulate logical and objective conclusions and make recommendations for effective solutions.


  • Supports Market Clinical Research Manager (MCRM), PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site; provide recommendations. Complete clinical portions of sponsors’ feasibility questionnaires.
  • Coordinate and participate in site initiation and other sponsor-required training for all protocols.
  • Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll participants in trials.
  • 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.
  • Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
  • Obtain PI signatures on all required study documents.
  • 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.
  • 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.
  • With appropriate training/credentialing, may perform blood draws, ECGs, and other testing, i.e., NIH Stroke Scale, as required by research protocols.
  • 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.
  • Serve as liaison between participants, physician investigators, sponsors of research, IRBs, DHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
  • Complete CRC activity reports accurately, and submit in a timely manner.
  • Attend investigator/coordinator meetings as required by study sponsors.
  • Flex work schedule as needed to accommodate participant visits, sponsor deadlines or program needs; work hours as needed--which may exceed 40 hours per week--based on workload and deadlines.
  • Other duties as assigned
  • 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.
  • MUST be willing to Float
  • 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.
  • Experience with Microsoft Office software required.
  • Knowledge of medical terminology required.
  • 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.
  • BLS (AHA)
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