Clinical Research Coordinator

About the role

Culmen International, LLC is hiring a Clinical Research Coordinator to assist the Naval Medical Center in Portsmouth, VA. This position will support the Department Head of CID and is accountable for research related matters to the PIs of each research protocol.

Responsibilities

• Coordinate research activities of assigned IRB and IACUC-approved study protocols, such as IRB pediatric and adult studies or IACUC animal studies.
• Support the Department Head of CID and the PI of each protocol in accordance with written policies and procedures as set forth in Title 21 of the Code of Federal Regulations, NMCP and Bureau of Medicine & Surgery (BUMED) instructions.
• Ensure all studies performed are in accordance with the approved protocol and applicable local, state, and federal regulations.
• Work closely with the Senior Research Technician/Supply Purchase officer in identifying the study materials, equipment and/or research animals needed in the research protocol and in accordance with CID IACUC policies and animal facility standard operating procedures.
• Coverage of work includes ambulatory care spaces, inpatient wards, and the animal vivarium, all of which present some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons.
• Avoid direct patient contact but may interact with patients, their families and/or significant others, providers, clinical staff, clerical staff, and collaborative institutions.
• Report data on research studies in accordance with IRB/IACUC-approved protocols and applicable regulations with final government approval.
• Absorb and communicate protocol inclusion/exclusion criteria and refer eligible patients to the PI for final evaluation.
• Absorb and communicate with Government personnel to ensure the consent process has taken place effectively and all questions are answered satisfactorily and documented.
• Absorb and communicate with patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator.
• Absorb and perform phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol.
• Maintain proficiency required to coordinate clinical research such as: communication skills and leadership skills as the coordinator of complex human and animal research protocols.
• Maintain proficiency in appointment booking, and coordinating laboratory studies, x-rays, and other tests.
• Assign appropriate randomization number, per protocol design, to subjects.
• Absorb and ensure correct dispensing of drugs as per protocol by the Research Pharmacist.
• Absorb and maintain accurate documentation record of drugs received.
• Absorb and prepare specimens for lab analysis and shipping.
• Observe universal precautions and OSHA standards when processing or handling specimens.
• Collect laboratory results and consult with the PI for follow-up care.
• Maintain proficiency in collecting data in a timely and accurate manner and submitting information to coordinating centers as required, subject to final government approval.
• Maintain proficiency in reporting of adverse events to the governing agencies (IRB/IACUC) and sponsors as required by protocol and regulations.
• Maintain proficiency in ensuring the research study is in compliance with regulations and standard operating procedures, to include complete documentation of status and progress.
• Maintain proficiency in maintaining detailed documentation of the research study as required by the protocol and the PI’s File Binder/Regulatory Binder.
• Maintain proficiency in preparing reports and other correspondence regarding the research protocol for IACUC, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol, subject to final government approval.
• Maintain proficiency in producing protocol amendments and continuing reviews in the eIRB system, subject to final government approval.
• Maintain proficiency in submitting deviation study reports to the IACUC/IRB, subject to final government approval.
• Absorb and attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.

Qualifications

Subcontractor personnel shall not function as voting members.