Clinical Research Nurse (protocol development)

Chenega Corporation•Bethesda, MD

5d•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 role supports clinical research protocol development, implementation, and management while ensuring human-subject protections and patient-centered care throughout participation in clinical research. The nurse works with principal investigators (PIs), healthcare team members, patients, families, regulatory bodies, and referral sources to support clinical trials and collaborative research projects. The position includes clinical trial coordination and participant care, informed consent support, recruitment and retention, protocol compliance, documentation and data management, regulatory reporting, and development of study-specific materials and standards. The nurse also supports data capture and management plans, monitors participants for adverse events, contributes to audits, and mentors clinical trials nurses and other research team members. The position is onsite at 9000 Rockville Pike, Bethesda, MD.

Requirements

Minimum of an R.N. degree.
Licensed as a nurse in any U.S. 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 of patient privacy, privileged information, and secure handling of 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 literate.
Successfully pass background and drug screening.
Ability to meet the physical demands of the role, including occasionally lifting and/or moving up to 25 pounds.

Nice To Haves

NIH clinical trials experience is preferred.

Responsibilities

Ensure human-subject protections and patient-oriented care throughout research participation.
Assist with protocol development, implementation, and management, including oversight of concise, verifiable data collection.
Support protocol compliance, clinical trial collaboration, ethical standards, informed consent, participant recruitment and retention, patient management, documentation, data management, and information technology activities.
Assist in developing clinical research and protocol-specific standards of practice (SOPs).
Collaborate 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.
Work with PIs to resolve protocol implementation problems during study design and to create or revise data-capture forms.
Collaborate with healthcare team members in trial execution and management; communicate findings and suggestions to PIs; report clinical data to regulatory and monitoring agencies; produce clinical reports; and summarize clinical data as requested.
Develop supplemental materials for IRB approval to support informed consent and provide ongoing patient and family counseling 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 study materials with PI input and IRB approval.
Interview and evaluate patients screened for clinical trial entry.
Develop patient education materials for individual studies and obtain IRB and sponsor approval as required.
Assess and address trends affecting participant adherence to protocol-specific activities.
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.
Ensure timely appointment and testing schedules and careful acquisition and distribution of clinical samples.
Ensure protocol-required testing is scheduled and patient visits follow protocol guidelines.
Remain involved in all aspects of the clinical trial process and update patient care areas on protocol processes, progress, and events affecting care or data collection.
Coordinate participant care according to study scope, patient clinical condition, and the effects of clinical care on 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, or forms.
Assist PIs in developing data management plans for each clinical trial and 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 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.