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. 

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 are determined by the scope of the study participation and clinical conditions of the patient and the clinical effects on research procedures.
• Monitors the research participant for adverse events and reports to the study PI. Investigates the etiology of discrepancies or unusual sentinel events and provides feedback and recommendations for resolution and problem prevention.
• Participates in the development of approved source documents, templates, or forms.
• Participates in the preparation of reports for appropriate regulatory agencies and monitoring bodies or boards.
• Assists the principal investigator in developing data management plans for each clinical trial.
• Uses information management and computer technology to support clinical data management activities.
• Assists in developing case reporting forms (CRFs) for multisite clinical trials.
• Participates in and directs organizational audits performed by sponsor and/or regulatory agencies.
• Pursues opportunities to participate in local or national research-related activities (e.g., professional nursing and/or research organizations, institutional committees).
• Provides mentorship to new clinical trials nurses, research team members, and other healthcare providers.
• Performs other duties and responsibilities as assigned.
• Other duties as assigned

Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)  

• Minimum of an R.N. degree.
• Licensed as a nurse in any US State.
• Must be able to be credentialed by the NIH Clinical Center.
• Knowledge of environmental safety, including infection control, isolation technique, and general security.
• Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient’s medical records
• Knowledge of federal regulatory requirements pertaining to clinical research
• NIH clinical trials experience preferred
• Successfully pass background and drug screening

Knowledge, Skills and Abilities:  

• Ability to read, write, and speak English well enough to effectively communicate with all parties.
• Computer literate.

Physical Demands: (The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.) 

• • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee may use repeated motions that include the arms, wrists, hands and/or fingers. The employee is occasionally required to walk, stand, climb, balance, stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision.