Clinical Research Nurse Coordinator - Portsmouth, United States - Odyssey Systems

Description

Odyssey is seeking a Registered Nurse (RN) for a Clinical Research Nurse Coordinator position to support the Clinical Investigation Department (CID) in the Cancer Coordination Center at the Navy Medical Center, Portsmouth (NMCP) Virginia. The mission of the command is to support the national interests of the United States by providing professional education and development, providing quality patient care, being responsive and ready for deployment, and taking care of each other as shipmates. NMCP conducts biomedical research in general surgery, psychology, otolaryngology, pediatrics, nursing research, orthopedics, women's health, and emergency medicine, which are relevant to the Graduate Medical Education Program.

Duties include, but not limited to:

• Providing nursing research support for IRB and Institutional Animal Care and Utilization Committee (IACUC) approved research protocols.
• Provide support to the Department Head of the CID, Directorate for Professional Education, and Naval Medical Center Portsmouth (NMCP).
• Support research activities of assigned IRB-approved study protocols, including supporting the Principal Investigator (PI) and CID Department Head in accordance with federal and local regulatory guidelines.
• Support research activities and patient care according to assigned IRB-approved protocols, such as physical assessments, vital signs, assessing specific signs and symptoms, and drawing blood (if applicable).
• Administers investigational drugs as specified in the protocols.
• Use programs such as clinical computer systems, including Composite Health Care System (CHCS-I) and Gensis, for consultation, reporting, exchange of information, orientation, support in the performance of assigned duties, and to guide patients through a research protocol.
• Maintain and document contact with study subjects and research personnel from Government agencies, granting agencies, and industry sponsors.
• Provide IRB/HRPP support to the PI in developing and implementing 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 have been answered satisfactorily, and the process has been documented.
• Assist the research pharmacist with correct receipt, dispensation, and accountability/documentation of investigational drugs per the sponsor protocol on
• Investigational Drug/Device Accountability.
• Educate subjects on compliance, possible side effects, drug interactions, and the importance of contacting the coordinator and study team members as applicable.
• Assist with maintaining an 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 maintaining 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.
• Process and prepare specimens for lab analysis and shipment, as applicable and directed by the PI. 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 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 discrepancies/findings and, after consultation with PI, communicate approved recommendations. Conduct telephone and 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.
• Provide instruction and presentation material, and assistance to research staff, as needed, for CID departmental and command-wide research educational and training programs. In collaboration with the PI, conduct periodic self-audits of research studies for 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.

Minimum Required Qualifications:

Citizenship: Must be a US citizen

Clearance: Secret (Ability to Obtain)

Education: BS or higher

Years experience: Minimum of two (2) years experience coordinating research protocols OR (2) years experience in cancer research 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)

Certifications: Registered Nurse (RN)

Skills:

• Experience supporting research protocols for IRB and Institutional Animal Care and Utilization Committee (IACUC)
• Working knowledge of United States Federal government regulations regarding the conduct of human clinical research.
• Clinical competence in the application of professional nursing theory, practices, and skills for the care of pediatric and adult patients.
• Ability to communicate effectively in written and verbal modes and to teach in formal and informal settings.
• Skilled in counseling, providing guidance, and maintaining interpersonal relationships.
• Proficient in typing for online documentation of patient interactions.
• Ability to concentrate, stand, and/or walk for extended periods on a regular basis and work well under pressure in often changing conditions and research workload.
• Must possess the ability to complete research subject protection training developed by the Collaborative Institutional Training Initiative (CITI) training and additional protocol training, as required, within one (1) month from the start date.

Additional Information:

Location: Navy Medical Center, Portsmouth (NMCP) Virginia; Must be within a commutable distance of NMCP as onsite work is required

Travel: Up to 10%

Remote, Onsite, or Hybrid: Onsite (telework eligible); local candidates only

Odyssey Systems Consulting Group is an innovative small business committed to providing world-class technical, management, and training support services to government and public sector clients. We focus on people, processes, and performance to deliver superior results. Since our inception in 1997, our commitment to mission success and customer satisfaction has been recognized with exponential growth and exceptional past performance ratings. We accept challenging assignments and drive projects from the planning stages through implementation and into operations and support.

Please note: Final compensation for this position will be determined by various factors such as the Federal Government contract labor categories and contract wage rates, relevant work experience, specific skills and competencies, geographic location, education, and certifications.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities