Clinical Research Coordinator - Military veterans preferred
2019-01-11 General Dynamics Information Technology (www.gdit.com)
Portsmouth Virginia United States
GDIT is seeking a Clinical Research Coordinator (CRC) to support the Naval Medical Center in Portsmouth, VA (NMCP). The mission of NMCP is to support the national interests of the United States by providing professional education and development, providing quality patient care, and being responsive and ready for deployment. NMCP conducts biomedical research in combat casualty care. The purpose of this position 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 Professional Education, NMCP, VA. The position will coordinate and conduct human clinical research in conjunction with the Principal Investigators (PI) of IRB-approved research protocols
Supports the Department Head of CID and is 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, etc., 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, teaching, support for the performance of duties, and to guide patients through a research protocol, will maintain and document contact with study subjects and research personnel from government agencies, granting agencies, industry sponsors, etc.
Work with the PI to develop and implement recruitment strategies in accordance with IRB/HRPO requirements and approvals.
Recruit and screen research subjects using protocol inclusion/exclusion criteria. Refer eligible subjects to the PI for final evaluation, enrollment, and randomization per protocol design.
Ensure the informed consent process has taken place effectively, all subject questions are answered satisfactorily, and the process is documented.
In collaboration with the research pharmacist, ensure correct receipt, dispensation and accountability/documentation of investigational drugs per the sponsor protocol on Investigational Drug/Device Accountability.
Ensure subjects receive education on compliance, possible side effects, drug interactions and the importance of contacting the coordinator and study team members as applicable.
Ensure adequate inventory of study supplies, including drugs, devices, etc.
Prepare other study materials as requested by the PI. These study materials include, but are not limited to, 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 in development of materials and tools necessary to appropriately train individuals involved in the execution of a study related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Train appropriate personnel as needed. Maintain documentation of training.
Coordinate 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 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 as required.
Report and document adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
Evaluate compliance of research subject and complete documentation of status and progress.
Respond to compliance Officer audit findings and, after consultation with PI, implement 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 but not limited to 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, the PI, or sponsoring agency.
Return telephone calls from research participants in an efficient and timely manner and documents 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 according to HIPAA and institutional regulations.
Actively participate in CID departmental and command-wide research educational and training programs by providing instruction, presentations, and assistance to research staff as needed.
Assist the compliance Officer with monitoring process to ensure protocol compliance.
Assist principal investigators, research team members, and other staff in the development of, preparation for, and closeout of clinical research studies.
Collaborate with PI, study personnel and CID grants writer to source research funding for future protocols.
Attend conferences and other meetings as required by the protocol, the PI or sponsoring agency as authorized by contract.
Perform other research related duties as needed.
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.
Clinical competence in application of professional nursing theory, practice, and skills for the care of pediatric and adult patients.
Ability to communicate effectively in written and oral modes and to teach in formal and informal settings.
Skills in counseling, guidance and maintaining interpersonal relationships.
Good typing skills to allow on-line documentation of patient interactions.
Complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and integrity training within one month from start date.
US citizenship is a contractual requirement with the ability to obtain or maintain a favorable T3 security investigations.
For more than 50 years, General Dynamics Information Technology has served as a trusted provider of information technology, systems engineering, training and professional services to customers across federal, state, and local governments, and in the commercial sector. Over 40,000 GDIT professionals deliver enterprise solutions, manage mission-critical IT programs and provide mission support services worldwide. GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.