Akahi Associates, LLC is seeking a highly qualified Research Nurse to work at our client site the National Human Genome Research Institute of Health in Bethesda, MD. This is a full-time position with benefits. 40 hours per week, Monday – Friday.
TASKS/SERVICES. The contractor shall:
- Provide support for clinical studies, including FDA-regulated clinical trials related to GNE myopathy.
- Provide daily updates to Leadership, study coordination staff, and the clinical team on IC study patient admittance to the NIH Clinical Center.
- Enter protocol orders.
- Schedule, plan, and coordinate study visits and protocol-related evaluations with patients, evaluators, and investigators.
- Collect and ship clinical laboratory samples as described in the protocol.
- Identify adverse events and notify Leadership.
- Monitor drug compliance by subjects throughout the life of the protocol; document missed doses.
- Participate in discharge planning; coordinate referral to community agencies; coordinate care with community providers.
- Provide patient/family support.
- Work with Leadership and protocol coordinator throughout the life cycle of the protocol.
- Review and understand the protocol study procedures, timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
- Assist in the recruitment and retention of patients into clinical protocols; maintain enrollment log.
- Coordinate and organize the educational aspects of studies to provide optimal participation, compliance, and minimize protocol deviations.
- Assist Leadership in communicating study requirements to all individuals involved in the studies.
- Monitor protocol compliance and adherence, including completion of evaluations and follow-up visits within the window required by the protocol, to minimize protocol deviations.
- Communicate with members of the team, including evaluators, consultants, laboratory, pharmacy, and nursing staff to ensure timely completion of all protocol-related evaluations and study drug administration.
- Inform patients on study diary, study drug administration, and other study requirements.
- Complete source documents (data collection).
- Maintain data integrity and retrieval and interpret needs for principal investigators, patients, and other staff.
- Implement the standards for research protocols in compliance with regulatory, institutional and external agencies.
- Participate in training/orientation program geared toward the Principles of Clinical Trials.
- Attend and participate in regularly scheduled clinical rounds and conferences.
DELIVERABLES. Upon request, the contractor shall provide documentation evidence of any and/or all work product, including, but not limited to, the following tasks:
- Work products and documents related to providing high-quality, timely patient care to clinical study participants.
- Work products and documents related to contacting and following-up with study participants.
- Work products and documents related to performing daily clinical team rounds.
· Work products and documents related to performing all patient-related evaluations.
CERTIFICATIONS, LICENSE, PHYSICAL REQUIREMENTS OR OTHER EXPERTISE REQUIRED. The contractor must have:
- Master’s degree in nursing. Three (3) years of specialized experience plus a BA/BS degree is equivalent to a Master’s degree. Current state nursing license
- Minimum of two (2) years of nursing experience with CPR certification. Experience in clinical research setting with protocols and clinical trials.
- Work collaboratively in a multi-disciplinary team of clinicians.
- ·Excellent analytical, organizational, verbal and written communication, and time management skills.
- Knowledge of maintaining accurate and detailed records.
- Rare disease interest or previous experience.
- Thorough knowledge of the regulations and guidance that govern the clinical trial process, including ICH Good Clinical Practices and FDA regulations.
For further information, please click [Register to View] to view the EEO Is The Law poster. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. Only qualified individuals who are being considered will be contacted for an interview.