Clinical Trial Registered Nurse - RN

Location and Shift Department/Unit: Emergency Medicine General Work Shift: Per Diem (United States of America) Salary Range: $78,773.63 - $122,099.12 Overview The Clinical Research Coordinator is responsible for the organization and management of multiple industry‑sponsored and investigator‑initiated clinical trials. The coordinator ensures accurate conduct of research studies, primarily focused on the protection and care of patients, through screening for eligibility, scheduling, physical assessments, biospecimen collection and processing, as well as data collection and study completion activities. The coordinator serves as the liaison among the principal investigator (PI), research site, study sponsor, and other vendors involved in the trial.

Responsibilities Attend site pre‑study visit/qualification visit meetings and Site Initiation Meetings, whether on site or remote. Attend Investigator Meetings either remote or at a location specified by the study sponsor (requires travel). Complete and submit new protocol feasibility questionnaires with research site information, including logistical capabilities and interdepartmental needs (radiology, operating room, inpatient).

Prepare and submit pre‑IRB approval documents for review and approval by institutional Research Pharmacy, Value Analysis (VAMS), Antibiotic Sub‑committee, Radiation. Prepare and submit regulatory documents required by federal regulations to the study sponsor/CRO prior to site initiation, and maintain them throughout the study, including 1572 (pharmaceutical trials). Submit financial disclosure forms for PI and Sub‑Investigators (SI), CV and medical license for PI and SI, current Human Subject Protection and Good Clinical Practice (GCP) training certificates, and IATA training certificates (if applicable).

Maintain delegation of authority/duty logs to indicate site personnel involved with the study and update as necessary. Prepare patient informed consent (ICF) and assent by inserting the AMC required language. Schedule study‑specific training visits for manager, pharmacy, clinical nursing units, operating room staff, etc.

Ensure all study‑required items are on‑site (tablet for questionnaires, lab supplies, devices). Develop original source data collection worksheets to comply with protocol‑specific data requirements, including adverse event logs and medication logs. Prepare initial IRB submission documents (AMC Checklist, IRB application, study protocol, ICF, other patient‑facing materials).

Prepare and submit annual continuing review reports and site termination report to the IRB of record. Prepare and submit changes to IRB‑approved study documents and to patient‑facing materials as requested by the study sponsor. Document the process and file a copy in the patient’s medical record.

Assess patients for eligibility using study‑specific inclusion and exclusion criteria. Perform patient health assessments, including vital signs, ECG, medication and medical history. Administer questionnaires to be completed by the patient (quality‑of‑life questionnaires, pain scores, etc.) and coordinate imaging studies such as radiology, ultrasounds and echocardiograms.

Coordinate medication infusions or nurse administration of study medication injections. Collect required data from the patient during procedure visits (clinic procedure room, operating room, cath lab, angio suite, etc.). Review intraoperative inclusion/exclusion criteria and collect required data before, during, and after the procedure.

Identify, document, and manage undesired side effects/adverse events, initiating clinical care to minimize them. Qualifications Experience in clinical research coordination, including oversight of industry‑sponsored and investigator‑initiated trials. Proficiency in managing IRB submissions, regulatory documentation, and compliance with federal regulations such as 1572.

Knowledge of Good Clinical Practice (GCP) and Human Subject Protection regulations. Strong organizational skills and ability to coordinate with multiple departments (radiology, operating room, inpatient, pharmacy). Ability to manage patient evaluations, informed consent process, and data collection in a clinical environment.

Strong communication and documentation skills for liaising with PIs, sponsors, CROs, and IRBs. Equal Employment Opportunity 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.

Reasonable efforts, consistent with Albany Medical Center policies and standards, shall be made to ensure that information is adequately protected from unauthorized access and modification. #J-18808-Ljbffr