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

Description

SPECIAL SKILLS:

  • 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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • 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
SUBMISSION REQUIREMENTS
  • 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.
CERTIFICATION REQUIREMENTS
  • BLS (AHA)
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