Research Nurse

Concentric Methods is seeking an experienced Research Nurse toindependently provide support services to satisfy the overall operational objectives of National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The primary objective is to provide services and deliverables through performance of support services.

The total hourly pay for this exempt position is$56.00for up to 40 hours per week. This rate represents the company's good faith and reasonable estimate of possible compensation at the time of posting. In addition, for eligible positions we offer a variety of benefits including specified holidays, paid leave, health insurance, dental insurance, vision insurance, life and disability insurance, tuition reimbursement, as well as 401K with company match. This job will be posted until filled or withdrawn.

Duties include:

• Work with staff to develop procedure manuals for clinical research protocols.
• Work with staff to create case report forms.
• Visit off-site collaborative centers.
• Implement ongoing protocol operations to ensure study compliance; troubleshoot possible protocol violations.
• Assist in maintaining current regulatory documentation from numerous ongoing clinicalresearch protocols.
• Interface with NHGRI, NIAMS/NIDDK or other relevant Institutional Review Board
• (IRB); coordinate filing of UPs, AEs, amendments, continuing review applications, annual reports, protocol inactivation, and other regulatory documents.
• Assist in the management of research subject files, copying and organizing research data.
• Assist in updates for clinical staff on patient care, protocol process and progress, human rights protection, ICH Good Clinical Practices and quality assurance education.
• Collaborate with PIs to interpret research data for protocol team.
• Assist investigators and medical writers on the production/revision of clinical research protocols
• Support the needs of data integrity and retrieval.
• Participate in quality improvement and quality assurance initiatives involving database and data system development efforts.
• Assist in the identification of the responsible party for data input into ClinicalTrials.gov at study conclusion, as applicable.
• Participate in efforts to ensure scientific quality and human subject's protection.
• Interact with auditing and monitoring agencies to facilitate the exchange of data.
• Interface with the other protocol support personnel.
• Provide clinical care and nursing support (assessing/planning/following-up with disease-noted attributes, working with medical staff on procedures, ordering protocol-mandated tests/labs/procedures, teaching patients/subjects, serving as liaison for clinic and lab personnel and PI, following subjects between visits) for human microbiome outpatient research programs in the Cutaneous Microbiome and Inflammation Section, Dermatology, NIAMS.
• Via established guidelines, document patient care and research activities, maintain current regulatory documentation from numerous ongoing clinical research protocols, support the needs of data integrity and retrieval, assist in the management of research subject files including copying and organizing research data, participate in quality improvement and quality assurance initiatives involving database and data system development efforts, and interact with auditing and monitoring agencies to facilitate the exchange of data.
• Assess, plan and follow up with disease noted attributes.
• Coordinate various activities (including research subject schedules, data and biospecimen collection, and nursing care) to ensure proper and timely filing of standard clinical/regulatory documentation, serious adverse events, amendments, annual reports, and other regulatory documents.
• Order protocol-mandated tests, labs, and procedures.
• Distribute biospecimen kits, coordinate biospecimens for testing and diagnostic and research purposes (including referring MDs, NIH labs and repositories) and log biospecimen samples in appropriate database.
• Follow subjects between visits; collaborate with community physicians to further the continuity of care and protect the integrity of the clinical research protocol/data.
• Serve as liaison between clinical and laboratory sites, and with Principal Investigators (PIs).
• Work with staff on clinical research protocol development.
• Recruit and enroll research subjects.
• Develop patient rapport and assist in explaining the protocol and tests/procedures to the patients.
• Consult with health care professionals regarding medical, psychological, and/or social patient needs.
• Work with medical staff on skilled procedures.