Clinical Research Nurse (RN)

Overview: The Strelitz Diabetes Center at Eastern Virginia Medical School is searching for a Clinical Research Nurse to work on clinical studies involving diabetes, diabetic neuropathy, metabolic disorders and cardiovascular disease.
The primary responsibility of the Clinical Research Nurse is to manage all aspects of conducting clinical research and trials.
The Clinical Research Nurse is required to have an in-depth knowledge of protocol requirements and good clinical practices as set forth by federal regulations.
As the primary resource for the protocols, the Clinical Research Nurse will act as liaison between the study subjects, coordinators, investigators, primary care providers and the sponsor.
Along with the investigator, the Clinical Research Nurse will screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study.
In addition, the Clinical Research Coordinator is responsible for all data and source documentation, adverse experience reporting, and maintenance of complete regulatory files.
Responsibilities: Possess a sound and in-depth understanding of each study protocol.
Complete and pass the required courses/tests/certificates and human subjects/ethics training course.
Serve as the main point of contact with responsible parties.
Perform physical exams on study patients with oversight of PI/Co-I.
Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility.
Review concomitant medications for participants in clinical trials.
Perform and review ECGs in collaboration with PI/Co-PI.
Perform medical follow ups, when needed with oversight of PI/Co-I.
Review blood pressure results, self-monitoring of blood glucose (SMBG) as well as all lab results with oversight of PI/Co-I; and communicate abnormal values to the primary care provider, as appropriate Perform study procedures as needed when appropriately delegated by PI/Co-I.
Review with the principal investigator and other study staff the inclusion/exclusion criteria, overall structure, and requirements of each protocol.
Submit all study materials to the appropriate IRB for approval.
Develop and distribute study materials as needed.
Develop a mechanism for subject recruitment and ongoing communications with primary care physicians and study staff, as appropriate.
Assist in submitting amendments, continuing review reports and adverse events to the IRB.
Review the protocol, informed consent form, and follow-up procedures with potential study subjects.
Ensure the subject understands the study prior to signing the consent form.
Ensure the current approved informed consent is signed before subjects are screened and enrolled.
Administer and complete the required assessment questionnaires.
Ensure that the randomization procedure is followed as per protocol guidelines.
Document protocol exemptions and deviations, as appropriate.
Ensure adherence to protocol requirements.
Schedule subjects for follow-up visits, as needed.
Maintain telephone contact with subjects in between visits, as needed.
Assess subject response to therapy and evaluate for adverse events.
Assess and document subject compliance with medications and visits.
Administer study drug therapy as needed and maintains the study drug dispensing logs.
Ensure appropriate specimen collection.
Attend study-related meetings as appropriate.
Communicate regularly with the principal investigator and other study team members about study-related issues.
Coordinate the activities of various research team members to ensure completion of study objectives.
Ensure timely and accurate case report form (CRF) completion for each study subject.
Maintain source documentation for all CRF entries, including clinic chart visit notes, lab data, and procedure reports.
Provide auditors/monitors with completed CRFs, medical records, lab data and other source documents for review.
Assess and record all adverse events as outlined in protocol.
Report all serious adverse events to the principal investigator, sponsor’s monitor, primary care physician, if appropriate, and IRB as outlined in the protocol.
Maintain copies of all required regulatory documents in an organized manner.
Attend and participate in weekly/monthly clinical research meetings, weekly/monthly general research meetings and required weekly/monthly educational programs.
Perform data entry for the study and other duties as assigned.
Qualifications: Bachelor of Nursing degree.
Five (5) years’ experience with clinical research studies and trials.
Must have a valid Virginia license as a Professional Registered Nurse.
Location : Location: US-VA-Norfolk