RN - Clinical Research Nurse - NE
4 days ago
Greenville
Department/Unit: Emergency Medicine General Work Shift: Per Diem (United States of America) Salary Range: $78,773.63 - $122,099.12 The clinical research coordinator is responsible for the organization and management of multiple industry sponsored and Investigator initiated clinical trials. The position is accountable for assisting in the timely and accurate conduct of research studies, being concerned primarily for the protection and care of the patient as a research patient from initiation to completion of study. Activities include participating in the study start up and termination procedures, working with study participants in various study tasks including patient recruitment, screening for eligibility, scheduling, physical assessments and biospecimen collection and processing, as well as data collection and study completion activities. The research coordinator serves as the liaison between PI and research site and the study sponsor and other vendors working on the trial. B. Pre-Study Initiation 1. Attend site pre-study visit/qualification visit meetings and Site Initiation Meeting, whether on site or remote, 2. Attend Investigator Meeting either remote or at location specified by the study sponsor (requires travel), 3. Complete and submit new protocol feasibility questionnaires with research site information., 4. Review confidentiality forms in conjunction with the ORA and obtain appropriate signatures f. IATA training certificates (if applicable for the study) 8. Complete the delegation of authority/duty logs to indicate the site personnel involved with the study and update as necessary throughout the course of the study with either new study personnel or personnel that is no longer involved with the study. 9. Prepare the patient informed consent (ICF) and assent (if applicable) by inserting the AMC required language into the sponsors ICF template and submitting to the sponsor for approval prior to IRB submission 10. Prepare for study site initiation visit a. Schedule visit and all required personnel (PI, sub-investigators, coordinators, research manager, pharmacy, clinical nursing units, operating room staff, etc.) to be present b. Schedule study specific training visits, c. Ensure all study required items are on-site (tablets for questionnaires, lab supplies, devices, study medication/investigational products, EKG machine, etc.) C. IRB 3. Prepare and submit annual continuing review reports and site termination report to the IRB of record, 5. Prepare and submit protocol deviations and/or violations to the study sponsor and IRB as necessary D. Patient Interactions 1. Participate in or conduct the informed consent process and HIPAA authorization, per AMC SOP, with research participants through discussion of the study protocol, procedures, timelines, risks, benefits and answering any questions. Obtain the appropriate signatures and dates/time on the ICF form and documents the process and file a copy in the patient’s medical record. Assures that patients sign any future amended versions of the consent if applicable. 2. Develop study schedule and required procedures, timelines, and deadlines with study patient and family, the PI and research team. 3. Coordinate patient follow-up study visits, treatments, testing, procedures, and schedules 4. Conduct patient study visits and required assessments per each individual protocol, 5. Assess patients for eligibility using the study specific inclusion and exclusion criteria., 7. Obtain required biological specimens from patient, i.e., urine, sputum, etc., 8. Perform blood draw to obtain blood specimens, 9. Administer study specific scales; i.e. stroke scales, mental assessments, etc., 11. Perform POC testing as applicable per SOP, i.e. urine pregnancy, urine drug test, blood sugar, urinalysis, 13. Dispense to patient and train patient on completion of study diary, if applicable, 14. Review completed patient diaries with patient, 16. Review oral study medication compliance with patient at each visit, 17. Collect required data from the patient Thank you for your interest in Albany Medical Center! Albany Medical is an equal opportunity employer. This role may require access to information considered sensitive to Albany Medical Center, its patients, affiliates, and partners, including but not limited to HIPAA Protected Health Information and other information regulated by Federal and New York State statutes. Workforce members are expected to ensure that: Access to information is based on a “need to know” and is the minimum necessary to properly perform assigned duties. Use or disclosure shall not exceed the minimum amount of information needed to accomplish an intended purpose. Reasonable efforts, consistent with Albany Med Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification.
