Clinical Research Coordinator ( R-00064487 )
The Clinical Research Coordinator will provide research support services to support the Clinical Investigation Department (CID) at the Navy Medical Center, Portsmouth (NMCP) Virginia.
Provide research support for IRB and IACUC approved research protocols.
Organizationally support the Department Head of the CID, Directorate for Professional Education, NMCP. Support the Department Head of CID and be accountable for research matters to the PIs of each research protocol in accordance with federal and local regulatory guidelines.
Use programs such as Word, Excel, as well as clinical computer systems including Composite Health Care System (CHCS-I) and Armed Forces Health Longitudinal Technology Application (AHLTA).
For consultation, reporting, exchange of information, orientation support for the performance of duties, and to guide patients through a research protocol, maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors.
Provide IRB/HRPP support to the PI in the development and implementation of recruitment strategies in accordance with IRB/HRPP requirements and approvals.
Screen recruited research subjects using protocol inclusion/exclusion criteria.
Refer eligible patients to the PI for final evaluation, enrollment, and randomization per protocol design after the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented.
Assist the research pharmacist with correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability.
Provide subjects with education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable.
Assist with maintaining adequate inventory of study supplies, including drugs, and devices, and preparation of other study materials. These study materials include the informed consent document, case report forms (CRFs)/data collection forms (DCFs), enrollment logs, concomitant medication/adverse events logs and drug/device accountability logs.
Assist the PI by providing materials and tools necessary for the development of appropriate training of individuals involved in the execution of a study related to protocol requirements, schedule of visits, execution of research plan, and maintain documentation of training.
In collaboration with the PI, check on the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol.
Observe universal precautions and OSHA standards when processing or handling specimens.
Obtain laboratory results and consult with the PI for follow-up care as per protocol.
Collect data in a timely and accurate manner and submit information to coordinating centers.
Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
Review compliance of research subject and complete documentation of status and progress.
Respond to Assurance Specialist discrepancy/findings and, after consultation with PI, communicate approved recommendations.
Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol.
Maintain detailed documentation of the research study including subject study charts and databases as required by the protocol, and the Investigator’s File Binder or 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 and study team members regarding the conduct of the research study.
Attend conferences and other meetings as required by the protocol.
Return telephone calls from research participants within 48 hours and document interactions appropriately.
Work is performed in ambulatory care spaces and inpatient wards 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.
Maintain patient confidentiality in accordance with HIPAA and institutional regulations.
Actively participate in CID departmental and command-wide research educational and training programs by providing instruction and presentation materials to assist research staff, as needed.
Actively participate in assurance assist visits and regulatory audits for protocol compliance.
Assist PI, research team members, and other staff in the preparation of and closeout of clinical research studies.
Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols.
Bachelor’s Degree from an accredited college or university and a minimum experience of 2 years as a Clinical Research Coordinator within the past five years or current 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).
Minimum of 2-4 years of monitoring experience in a clinical research environment and administrative Institutional Review Board (IRB) experience.
Possess knowledge of medical terminology and clinical monitoring process and in depth therapeutic and protocol knowledge.
Ability to communicate effectively, both orally and in writing.
Possess effective organizational and analytical skills with ability to work independently and in a team environment.
Proficiency with Windows base computer systems, including Microsoft Windows and Microsoft Office Suites program.
Must possess an active/current secret security clearance.
Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITTI), and additional protocol specific training, as required, within one month from start date.
Complete protocol specific training, as required, within one month from start date
Previous military R&D experience