GDIT is seeking a Clinical Research Nurse Coordinator (CRNC) in support of the Naval Medical Center Portsmouth (NMCP)s Clinical Investigations Department (CID).
The CRNC is responsible for coordinating the research activities of IRB-approved study protocols. Protocols will include both pediatric and adult patients.
Competitive compensation package offered including sign on bonus
Responsible for coordinating the research activities of assigned IRB-approved study protocols. Report to and is responsible to the Principal Investigator (PI) and supports the CID department head in accordance with federal and local regulatory guidelines.
Coordinate research activities and direct patient care of assigned IRB approved protocols such as physical assessments, vital signs, assessing specific signs and symptoms, and drawing blood (if applicable). Administer investigational drugs as specified in the protocols.
Recruit and screen research subjects using protocol inclusion/exclusion criteria. Conduct telephone, face-to-face interviews or mail information for follow-up visits as per protocol. 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.
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. Ensure adequate inventory of study supplies, including drugs, devices, etc. Prepare other study materials as requested by the PI.
Coordinate the performance of phlebotomies, electrocardiograms, vital signs, specimen collection and shipment, and other procedures as required by the protocol. Process and prepare specimens for lab analysis and shipping as applicable. Observe universal precautions and OSHA standards when processing or handling specimens.
Collect data in a timely and accurate manner and submit information to coordinating centers as required. Report adverse events and unanticipated problems to governing agencies and sponsors as required by protocol and regulations.
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.
Assist PI, 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. Maintain patient confidentiality according to HIPAA and institutional regulations.
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). Attend conferences and other meetings as required by the protocol, the PI, or sponsoring agency.
Registered Nurse (RN) required and a Bachelors degree
A minimum of 2+ years’ experience coordinating research protocols, OR certification in 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
Complete human subject protection training developed by the Collaborative Institutional Training Initiative (CITI), and integrity training within one month from start date
Must be a US citizen with the ability to obtain a favorable NACLC T3 security investigation
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 online documentation of patient interactions.
WHAT GDIT CAN OFFER YOU:
Competitive compensation package including sign on bonus
401K with company match
Customizable health benefits packages
Internal mobility team dedicated to helping you own your career
Challenging work that makes a real impact on the world around you
Full-flex work week
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
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.