Clinical Research Nurse (protocol development)

Chenega Services & Federal Solutions•Bethesda, MD

4d•Onsite

About The Position

Chenega Services and Federal Solutions (CSFS) is seeking a Research Nurse to provide support services to the National Institutes of Health (NIH) Clinical Center. The position supports clinical research protocol development, implementation, and management while protecting human subjects and maintaining a patient-oriented approach throughout participants’ involvement in research. The role is onsite at 9000 Rockville Pike, Bethesda, Maryland. The nurse works with principal investigators (PIs), interdisciplinary healthcare teams, study participants, families, referral sources, sponsors, and regulatory bodies. Responsibilities span participant screening and care coordination; informed consent and patient education; protocol compliance; clinical and data management; regulatory reporting; and the development of study materials, source documents, procedures, and forms. The nurse also monitors participants for adverse events, supports audits, contributes to process improvement, and mentors clinical research colleagues. The employer describes a robust employee benefits program, engaged management, quality leadership, teamwork, performance recognition, and promotion opportunities.

Requirements

Minimum of an R.N. degree.
Licensed as a nurse in any U.S. state.
Must be eligible to be credentialed by the NIH Clinical Center.
Knowledge of environmental safety, including infection control, isolation technique, and general security.
Knowledge of patient privacy, privileged information, and secure handling of patient medical records.
Knowledge of federal regulatory requirements pertaining to clinical research.
Ability to read, write, and speak English well enough to communicate effectively with all parties.
Computer literacy.
Successfully pass background and drug screening.
Ability to meet the described physical demands, including occasional lifting or moving of up to 25 pounds.

Nice To Haves

NIH clinical trials experience is preferred.

Responsibilities

Protect human subjects and maintain a patient-oriented approach throughout participation in clinical research protocols.
Assist with protocol development, implementation, and management, including overseeing collection of concise, verifiable data.
Support protocol compliance, clinical trials as a co-investigator, collaborative projects, ethical practices, informed consent, recruitment and retention, patient management, documentation, data management, and information technology.
Help develop clinical research and protocol-specific standards of practice (SOPs).
Work with the principal investigator to finalize, implement, assess, and revise corrective and preventive action plans.
Participate in preparing reports for regulatory agencies, monitoring bodies, and boards.
Collaborate with PIs to resolve protocol implementation problems during the design period and create or revise data capture forms to meet study needs.
Collaborate with healthcare team members in trial execution and management; communicate findings and recommendations to PIs; report clinical data to regulatory and monitoring agencies; produce clinical-use and treatment decision-making reports; and summarize data as requested.
Develop supplemental materials that support informed consent and obtain institutional review board (IRB) approval as applicable.
Support informed consent by providing ongoing counseling to patients and families about clinical trials and the trial process.
Work with PIs to revise eligibility criteria or team processes, identify referral-process problems, and implement strategies to address them.
Develop materials with PI input and IRB approval.
Interview and evaluate patients screened for clinical trial entry.
Develop study-specific patient education materials and ensure IRB and sponsor approval as required.
Assess trends affecting patient adherence to protocol-specific activities and address them.
Communicate with physicians and web-based referral sources so physicians, patients, and families receive timely answers and referral information.
Collaborate with the interdisciplinary team to develop nursing practices that may improve patient outcomes.
Schedule patient appointments and testing in a timely manner and ensure careful acquisition and distribution of clinical samples.
Ensure protocol-required testing is arranged and patient visits follow protocol guidelines.
Remain involved in all aspects of the clinical trial process.
Update patient care areas on protocol processes and progress and events affecting clinical care and data collection.
Coordinate care for study participants according to study scope, patient clinical conditions, and effects of research procedures.
Monitor research participants for adverse events and report them to the study PI; investigate discrepancies or unusual sentinel events and recommend resolution and prevention measures.
Participate in developing approved source documents, templates, and forms.
Assist PIs in developing data management plans for each clinical trial.
Use information management and computer technology to support clinical data management.
Assist in developing case reporting forms (CRFs) for multisite clinical trials.
Participate in and direct organizational audits conducted by sponsors or regulatory agencies.
Pursue opportunities in local or national research-related activities, such as professional nursing or research organizations and institutional committees.
Mentor new clinical trials nurses, research team members, and other healthcare providers.
Perform other duties and responsibilities as assigned.