Concentric Methods is seeking a Registered Research Nurse to join our team in Bethesda, MD in support of the NIH.

Responsibilities:

• Utilize established resources to design study methods to meet study objectives.
• Work with staff to coordinate and collect epidemiologic, genetic, and clinical data.
• Participate in an interdisciplinary team supporting clinical evaluation and follow-up.
• Provide instruction to potential clinical study subjects and those involved in the care of subjects on aspects of the subject's care, treatments, and side effects.
• Provide patient education for protocol participants to ensure patient safety and protocol adherence.
• Monitor and support activities pertaining to clinical protocols, such as monitoring patient recruitment and retention, trial progress, and the need for extension or renewal of ongoing trials.
• Coordinate various activities to ensure proper filing of serious adverse events, amendments, annual reports, and other regulatory documents.
• Support the collection, data entry, and assistance with special procedures for patients.
• Organize and maintain an active referral list and master schedule for planning follow-up and new patient admissions.
• Collaborate with other members of the team in managing the patient's progress throughout treatment
• Obtain informed consent/assent as needed.
• Collaborate with other members of the team for the collection, processing, and handling of research and clinical laboratory samples inside and outside of NIH.
• Ensure that all aspects of Good Clinical Practice (GCP) are met or exceeded.
• Complete all source documentation and Case Report Form.
• Maintain thorough and organized study documentation, including research records, phone logs, screening logs, regulatory binders, and accurate drug accountability records.
• Provide expertise in patient care coordination and implementation of protocol requirements during onsite visits.
• Work with staff on the preparation and implementation of study protocols.
• Recruit and evaluate clinical study subjects, scheduling appointments, and interviews.
• Prepare IRB documentation, including initial submissions, protocol amendments, protocol modifications, Adverse Event Reports, protocol deviations, protocol violations, continuing review, and informed consent documents.

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