Clinical Research Coordinator
The mission of NMCP is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates. NMCP conducts biomedical research in general surgery, orthopedics, mental health and naval aerospace medicine which is relevant to the Graduate Medical Education Program. GDIT is seeking a clinical research coordinator will provide research coordinator support for Institutional Review Board (IRB)-approved clinical protocols. Activities include: Responsible for coordinating the research activities of assigned basic science, IRB and Institutional Animal Care and Use Committee (IACUC)-approved study protocols. Specific protocols that require the CRC’s support will be determined by the Department Head of CID in consultation with the CRC. Protocols may include both pediatric and adult patients, animals and human anatomical specimens (including cadavers).Supports the Department Head of CID and SERC Chair, and is accountable for research matters to the PIs of each research protocol. Work is evaluated by observation and outcomes for effectiveness of operations and compliance with scientific and ethical requirements as well as professional standards in terms of quality and appropriateness.Provides support to 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, NMOTC, and Bureau of Medicine & Surgery (BUMED) instructions. Independent judgment is exercised to determine appropriate action and priorities in the performance of duties.Will be adept in the use of managerial skills, communication skills and leadership skills as the coordinator of complex research protocols involving human beings, animals and human anatomical specimens.Must be proficient in appointment booking, appointing referrals, documenting telephone consults and other patient interactions, and coordinating laboratory studies, x-rays, and other tests. In order to accomplish these tasks, the contractor personnel must be proficient in the use of clinical computer systems, including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA).Personal contacts are with patients, their families and/or significant others, providers, clinical nurses, nursing department head, corps staff, respiratory staff and clerical staff. The CRC will also have frequent contacts with research personnel from government agencies, granting agencies and industry sponsors. Contacts will be for the purpose of consultation, reporting, exchange of information, orientation, teaching, support for the performance of duties, and to elicit positive behavioral response such as guiding patients through a research protocol. Shall report data on research patients in accordance with IRB-approved protocols and applicable regulations.Recruit and screen patients using protocol inclusion/exclusion criteria. Refer eligible patients to the PI for final evaluation.Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator.Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol.Collect clinical data in a timely and accurate manner and submit information to coordinating centers as required. Consult with the PI regarding follow-up care. Assist with data collection in animal and bioskills laboratory as needed.Assign appropriate patient randomization number per protocol design.Maintain official protocol binder with all required documentation per NMOTC and NMCP research instructions.Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.Ensure procedural adherence to the protocol; when protocol deviations occur, ensure deviations are appropriately reported and documented in the official protocol binderIn collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol.If applicable, maintain accurate documentation record of drugs received.Provide education to patients on compliance, possible side effects, drug interactions and the importance of contacting the coordinator.Coordinate the performance of phlebotomies, electrocardiograms, initiate intravenous infusions, vital signs, specimen collection and other procedures as required by the protocol.Process and prepare specimens for lab analysis and shipping.Observe universal precautions and OSHA standards when processing or handling specimens.Enter data into Microsoft Excel and Statistical Package for the Social Sciences (SPSS) databases.Transfer data from questionnaires and data sheets to the databases.Report adverse events to governing agencies and sponsors as required by protocol and regulations.Evaluate compliance of research subject and complete documentation of status and progress.Conduct telephone, face-to-face interviews or mail information for follow-up visits.Maintain detailed documentation of the research study including but not limited to individual patient files, databases as required by the protocol and the Investigator’s File Binder/Regulatory Binder.Prepare reports and other correspondence regarding the research protocol for the IRB, granting agencies, industry sponsors and other organizations as required by regulation and/or the protocol.Interact on a regular basis with the PI regarding the conduct of the research study.Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency.Returns telephone calls from research participants in an efficient and timely manner and documents interactions appropriately.Work is performed in ambulatory care spaces, inpatient wards, animal vivarium and bioskills laboratory with some risk of exposure to infectious disease, for which gloves, masks, or gowns provided by the government entity may be required for safety reasons.If properly trained, and required by the protocol, may extract blood or place bandages on animal subjects, assist with the restraint and handling of laboratory animals, surgical preparation, induction and maintenance of anesthesia, operation of physiologic monitoring equipment, collection and recording of anesthetic and experimental data and parameters.Provide other administrative duties that are within the scope of work. Education
- A Bachelor’s Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Master’s Degree or certification as a Registered Nurse will be given preference.
- A minimum of two years’ experience coordinating research protocols OR certification as a Certified Clinical Trial Investigator (CCTI), Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP) from the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SoCRA). Working knowledge of U.S. Federal government regulations regarding the conduct of human clinical research.Must be proficient in the use of clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA).Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings. Skills in counseling, guidance, and maintaining interpersonal relationships.Good typing skills to allow online documentation of patient interactions.Complete human protection training developed by the Collaborative Institutional Training Initiative (CITI) within one month from start date.Work requires concentration, periods of standing and walking on a regular basis. Must work well under pressure, often changing conditions and research workload.