Research Nurse

Cape Fox Shared Services; Bethesda (MD); On-site; USD 63,645 - 90,646; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401K with company match

Job summary

A healthcare services provider in Bethesda, MD seeks an experienced Research Nurse to support clinical research operations at the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Responsibilities include managing research subject files, maintaining regulatory documentation, and providing clinical care for research programs. Ideal candidates will have a Registered Nurse license, experience in clinical research, and strong collaboration skills.

Qualifications

• Experience with clinical research and patient care.
• Familiarity with Good Clinical Practices (GCP).
• Ability to coordinate complex schedules and maintain documentation.

Responsibilities

• Develop procedure manuals for clinical research protocols.
• Maintain regulatory documentation from ongoing protocols.
• Provide nursing support for research programs.

Skills

Clinical research protocols

Regulatory documentation management

Patient care

Data integrity

Collaboration with medical staff

Education

Registered Nurse (RN) License

Job description

Overview

Concentric Methods is seeking an experienced Research Nurse to independently 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 $56.00 for 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 This job will be posted until filled or withdrawn.

Responsibilities

• 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 for human microbiome outpatient research programs in the Cutaneous Microbiome and Inflammation Section, Dermatology, NIAMS, including assessing, planning, and following up with disease-noted attributes; working with medical staff on procedures; ordering protocol-mandated tests, labs, and procedures; teaching patients/subjects; serving as liaison for clinic and lab personnel and PI; following subjects between visits.
• Document patient care and research activities, maintain regulatory documentation, support data integrity and retrieval, manage research subject files, participate in quality improvement and QA initiatives, and interact with auditing and monitoring agencies to facilitate data exchange.
• Assess, plan and follow up with disease noted attributes.
• Coordinate 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/research purposes (including referring MDs, NIH labs and repositories) and log biospecimen samples in the appropriate database.
• Follow subjects between visits; collaborate with community physicians to maintain continuity of care and 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 patients.
• Consult with health care professionals regarding medical, psychological, and/or social patient needs.
• Work with medical staff on skilled procedures.