Clinical Trial Registered Nurse - RN

Department/Unit: Emergency Medicine General Work Shift: Per Diem (United States of America) The clinical research coordinator is responsible for the organization and management of multiple industry sponsored and Investigator initiated clinical trials. accurate conduct of research studies, being concerned primarily for the protection and care of the patient as a 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. Attend site pre-study visit/qualification visit meetings and Site Initiation Meeting, whether on site or remote Attend Investigator Meeting either remote or at location specified by the study sponsor (requires travel) Complete and submit new protocol feasibility questionnaires with research site information. logistical capabilities including interdepartmental needs, i.e. radiology, operating room, inpatient and Prepare and submit pre-IRB approval documents for review and approval by the following 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 during the course of the study 1572 (pharmaceutical trials) Financial Disclosure forms for PI and Sub Investigators (SI) CV and medical license for PI and Sub Investigators (SI) Current Human Subject Protection and Good Clinical Practice (GCP) training certificates for IATA training certificates (if applicable for the study) 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 Prepare the patient informed consent (ICF) and assent (if applicable) by inserting the AMC required language Prepare for study site initiation visit manager, pharmacy, clinical nursing units, operating room staff, etc.) Schedule study specific training visits, Ensure all study required items are on-site (tablets for questionnaires, lab supplies, devices, Develop original source data collection worksheets to comply with protocol specific data requirements to include adverse event logs, and medication logs to ensure all required patient data is collected.

Prepare initial IRB submission documents to include: 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 any changes to the IRB approved study documents as requested by the study sponsor changes to advertisements of patient facing materials with research participants through discussion of the study protocol, procedures, timelines, risks, benefits documents the process and file a copy in the patient's medical record. Assess patients for eligibility using the study specific inclusion and exclusion criteria. Perform patient health assessments to include but not limited to: Vital signs, EKG, medication and medical Administer questionnaires to be completed by the patient, i.e. quality of life questionnaires, pain scores, radiology, ultrasounds, echocardiograms, follow up study visits etc. medication infusions or coordinate with nurse to administer study medication injection.

Collect required data from the patient Procedure Visit -Clinic procedure room, Operating room, Cath lab, Angio suite, etc. Review intra operative inclusion/exclusion criteria Collect required data before, during and after the procedure untoward side effects/adverse events and initiate and coordinate clinical care to manage and minimize 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. 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.