Clinical Research Nurse; protocol development

Chenega Services and Federal Solutions (CSFS) is seeking a Research Nurse to provide support services to the National Institutes of Health (NIH) Clinical Center.

Our company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunities. We actively strive to channel ourhighly engaged employee’sknowledge, critical thinking, innovative solutions for our clients.

Work Location:

Onsite-9000 Rockville Pike, Bethesda, MD

• Ensures human subjects protections and patient-orientation during the course of a research subject’s participation in clinical research protocol.
• Assists with protocol development, implementation, and management including overseeing the collection of concise and verifiable data that contributes to public health.
• Performs duties in the following areas: protocol compliance, contributing as a co-investigator on clinical trials as well as various collaborative projects, adherence to ethical standards, informed consent, patient recruitment and retention, management of clinical trials patients, documentation and document management, data management and information technology
• Assists in developing clinical research and protocol-specific standards of practice (SOP).
• Collaborates with the principal investigator to finalize, ensure implementation, assess efficacy, and revise corrective and preventive action plans.
• Participates in the preparation of reports for appropriate regulatory agencies and monitoring bodies or boards.
• Collaborates with PIs to resolve protocol implementation problems during design period; uses and revises/creates data capture forms to meet study needs.
• Collaborates with health care members in the execution and management of trials; communicates findings and suggestions to the PI based on expertise; reports clinical data to regulatory and monitoring agencies; produces reports for clinical use and treatment decision-making; and summarizes clinical data as requested by PIs.
• Develops supplemental materials for institutional review board (IRB) approval that assist in the informed consent process.
• Supports the informed consent process by continually providing patient/family counseling related to clinical trials and to the clinical trials process.
• Collaborates with PIs to revise eligibility criteria or change team processes according to protocol. Identifies problems in referral process and implements strategies to handle problems.
• Develops materials with input of PIs and IRB approval.
• Interviews and evaluates all patients being screened for entry into clinical trials.
• Develops study-specific materials for patient education and ensures IRB and sponsor approval, as required.
• Assesses for and addresses trends that affect patient adherence to protocol‑specific activities.
• Interacts with physicians and web‑based referral sources to assure that physicians and/or patients and their families receive answers to their questions and appropriate referral information in a timely manner.
• Collaborates with the interdisciplinary team to develop nursing practices that have the potential to improve patient outcomes.
• Assures timely scheduling of patients for appointments/testing and careful acquisition and distribution of clinical samples.
• Assures that all protocol required testing has been scheduled and patient visits are scheduled in accordance with protocol guidelines.
• Maintains involvement in all aspects of the clinical trial process.
• Conducts updates for patient care areas on protocol process and progress, and events impacting clinical care and data collection.
• Coordinates care for study participants. Care requirements…