|Site:||Naval Medical Center Portsmouth|
All Counties in |
|Employment Type:||Full Time|
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The purpose of the work is to provide research coordinator support for Institutional Review Board (IRB)-approved clinical research protocols. This position organizationally supports the Department Head of the CID, Directorate for Graduate Medical Education, NMCP, VA. The position will coordinate and conduct human clinical research in conjunction with the Principal Investigators (PI) of IRB-approved research protocols.
This is for a contract solicitation.
| Responsible for coordinating the research activities of assigned IRB-approved study protocols. Specific protocols that require the CRCs support will be determined by the Department Head of CID in consultation with the CRC. Protocols will include both pediatric and adult patients.|
Supports the Department Head of CID 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 medical requirements and professional standards in terms of quality and appropriateness.
Provides support to the Department Head of CID and the Principal Investigators 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. 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.
Must be proficient in appointment booking, appointing referrals, documenting Telephone Consults and other patient interactions, coordinate laboratory studies, x-rays, and other tests. In order to accomplish this task, 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.
Assign appropriate patient randomization number per protocol design.
Ensure that the consent process has taken place effectively and all questions are answered satisfactorily and documented.
In collaboration with the Research Pharmacist, ensure that drugs are correctly dispensed as per protocol.
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.
Obtain laboratory results and consult with the PI for follow-up care.
Collect data in a timely and accurate manner and submit information to coordinating centers as required.
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.
| A Bachelors Degree or higher is required. Candidates with evidence of post-baccalaureate advanced education to include a Masters 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.
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.