Clinical Research Nurse
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.
Responsibilities:
- Responsible for coordinating the research activities of assigned IRB-approved study protocols
- Reports 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.
- Use managerial, communication (written and verbal) and leadership skills in all PI and human subject interaction.
- 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.
- 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.
- Process and prepare specimens for lab analysis and shipping as applicable. 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 as required.
- Report 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 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 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 the contract.
- Perform other research related duties as needed.
Qualifications:
Required:
- Registered Nurse (RN) with a Bachelor’s Degree required.
- 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.
- 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
Preferred:
- Masters degree preferred
- 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.