Non-Clinical – Clinical Research Coordinator (Varied)

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

• 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.