Clinical Trial Registered Nurse

ct and manage study data, ensuring study completion activities are performed accurately.
• Act as liaison between the principal investigator, research site, study sponsor, and other vendors.
• Attend site pre‑study visit/qualification visits and Site Initiation Meetings (on site or remote).
• Participate in Investigator Meetings (remote or on location specified by the study sponsor).
• Complete and submit new protocol feasibility questionnaires with research site information.
• Coordinate logistical needs across departments (radiology, operating room, inpatient, etc.).
• Prepare and submit pre‑IRB approval documents for review by the institutional review board and related committees.
• Prepare and submit regulatory documents required by federal regulations (e.g., 21 CFR 157.2 for pharmaceutical trials).
• Compile financial disclosure forms, CVs, medical licenses, and training certificates for principal investigators and sub‑investigators.
• Maintain delegation of authority/duty logs and update them as staff changes occur.
• Prepare patient informed consent forms and assent documents with required language.
• Plan and ensure all study‑related items (questionnaires, lab supplies, study devices) are on site prior to initiation.
• Develop original source data collection worksheets, adverse event logs, and medication logs to meet protocol requirements.
• Prepare initial IRB submission documents (IRB application, protocol, ICF, and other patient‑facing materials).
• Prepare and submit annual continuing review reports and site termination reports to the IRB of record.
• Submit and track changes to IRB‑approved study documents as requested by the study sponsor.
• Assess patients for eligibility using study‑specific inclusion and exclusion criteria.
• Perform patient health assessments: vital signs, EKG, medication review, and administer questionnaires (quality of life, pain scores, etc.).
• Coordinate imaging studies (radiology, ultrasound, echocardiograms) and follow‑up visits.
• Coordinate medication infusions or work with nursing staff to administer study medication injections.
• Collect required data before, during, and after procedures in various clinical settings (clinic, OR, Cath lab, Angio suite).
• Monitor and document adverse events, coordinating clinical care to manage and minimize side effects.

Qualifications
• Current Human Subject Protection and Good Clinical Practice (GCP) training certificates.
• IATA training certificates, if applicable for the study.
• Knowledge of federal regulations governing clinical trials (e.g., 21 CFR 157.2).
• Experience coordinating multiple clinical trials and working with institutional committees (IRB, Pharmacy, Radiology, etc.).
• Strong organizational skills and ability to manage complex logistical requirements.
• Excellent communication skills, capable of liaising with investigators, sponsors, vendors, and multidisciplinary staff.
• Demonstrated ability to develop accurate data collection tools and maintain study documentation.
• Attention to detail and commitment to patient safety and compliance with regulatory standards.

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.