The Research Nurse Coordinator (RNC) is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The RNC provides support, coordination and leadership for FDA regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government-funded clinical research and investigator-initiated clinical research. The RNC ensures a smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. This position reports to the Director of Clinical Research.
The RNC is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects. The RNC assists in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds. Responsible for submitting case report forms and other data to the Sponsor as necessary, and assists with monitoring, auditing, and close-out visits. Maintains knowledge of best practice and standards for Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. This position reports to the Director of Clinical Research and works as a team member to support the growth and vision of the Hoag Institute for Research and Education.
Job Specific Essential Functions:
- Assist the Principal Investigator (PI) in the conduct of the clinical study according to FDA and Sponsor regulations and guidelines and ensures the safety and welfare of the research participants.
- Designs, implements and manages a system for organizing, planning workflow related to all research study activities.
- Prepares and presents a summary of clinical trial activities if needed.
- Maintains up to date knowledge of study protocols to complete study activities correctly and completely.
- Design and/or maintain organizational tools to conduct the study accurately and in compliance with Good Clinical Practice.
- Develops forms, checklists and other tools to facilitate study completion and compliance.
- Assist the PI in the active recruitment and screening of potential research participants according to the protocol’s inclusion/exclusion criteria.
- Schedule research participant’s visits in accordance with the study protocol.
- Assist the PI in the training of other site personnel and other medical staff in understanding and implementing the protocol.
- Drafts or reviews template Informed Consent Forms with Clinical Research Office per FDA, ICH, GCP guidelines and Hoag Policy language.
- Discusses research study with potential research participants and answers any questions while coordinating the process of obtaining the research subjects informed consent prior to participation in the study.
- The RNC shall seek guidance from the Principal Investigator for any questions he/she cannot accurately answer for the research participant regarding the study or participant’s medical condition.
- Schedule or assist in scheduling follow-up visits for enrolled subjects
- Documents and reports Unanticipated Problems, Adverse Events, and Serious Adverse Events according to Clinical Research Office policy, Sponsor, IRB, FDA, ICH and GCP guidelines and specific protocol, to the Investigator, Sponsor, Clinical Research Office administrative staff, and IRB.
- Complete the Case Report Forms for the study accurately and completely.
- Abstract data from hospital record and physician charts to complete CRFs.
- Work with ancillary staff areas (e.g. Operating Nursing Care, Cath Lab, Pharmacy, Pathology, Radiology, Laboratory, Medical Records) within the hospital affected by research activities.
- Maintain accurate and complete records of the receipt, dispensing, and return of all investigational supplies, including study drug(s) or devices, and report any discrepancies to the PI and Sponsor.
- Maintain the required regulatory and other documentation in the study documentation file. Maintain records of research participants enrolled in the study.
- Communicate with the study sponsor regarding study activities as necessary. Participates in required study visits such as Initiation Visit, Routine Monitoring Visits, Close-out visits, and audits.
- Reviews study records and meet with site visit teams/monitors, the FDA, or other inspectors as designated by the sponsor when required.
- Resolves queries generated from Sponsor or other monitoring/auditing reports.
- Completes study Institutional Review Board submission application and ensures the Investigator's review.
- Communicate with the designated IRB on study approvals/closures, and adverse event reporting.
- Work with the Clinical Research Office (CRO) administrative staff on all required aspects of study submission, continuing reviews, adverse event reporting, and study closure.
- Maintains current knowledge of Clinical Research Policies and Procedures.
- Works with Clinical Research Office administrative staff in developing detailed cost analysis, study budget preparation, and tracking/distribution of study funds.
- Accommodates changes in workload within the department and demonstrates flexibility in accepting work assignments.
- Performs assignments as directed by the Supervisor.
- Perform clinical duties and assessments as needed (i.e. blood/lab draw, EKG, record vitals, CPR, BLS, ACLS certificate, taking physician orders, etc.)
- Perform other duties as assigned.
Education, Training, and Experience:
- One year of Clinical Research Coordinator experience or at least five years of experience in the specific medical specialty of the position.
- Patient coordination experience in complex clinical trial setting required.
- Maintain CPR, certifications (BLS, ACLS, NALS, PALS, E.P., etc.) as applicable per hospital policy.
- Maintain current license, certification, and registration
- Complete annual “house-wide mandatories” per hospital/department requirement
- Medical terminology required.
- Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines.
- Understanding of clinical trial methodologies and experience filing Institutional Review Board documents.
- Bachelor of Science in Nursing (BSN).
- Familiar with the medical area of neurosciences particularly in the areas of stroke, epilepsy, movement disorders, and cognitive disease.
- Familiar with medical areas of oncology, neurosciences, cardiovascular medicine, or orthopedic research.
License and Certifications:
- Current licensure in good standing as a Registered Nurse in the State of California.
- Holds a current Certified Clinical Research Coordinator Certificate (ACRP or SoCRA), or completed within two years of hire.
Position reports to the Director of Clinical Research