Clinical Trial Specialist Position Available In Onondaga, New York

Clinical Trial Specialist Job Description We are seeking a dedicated Clinical Trial Specialist to join our dynamic research team. The successful candidate will manage multiple research trials, including first-in-human through phase 3 trials, ensuring compliance with FDA guidelines and adherence to Good Clinical Practice (GCP). This role involves daily interactions with clinicians, sponsors, IRB, regulatory agencies, and other research professionals. Responsibilities Accurately prepare and maintain regulatory documents. Prepare Informed Consent Documents with institutional language. Interface with the IRB, preparing all required documents and submitting packages for review. Collaborate with the recruitment team to create advertising plans and enroll subjects. Monitor each subject’s schedule for compliance with the protocol. Attend study meetings both internally and externally. Train the study team on new and amended protocols. Assist in operational planning for study visits, communicating needs to administration. Create source documents to collect required data in RedCap and oversee team entries. Assist in the execution of Informed Consent. Enter data into study-specific databases. Required Skills & Qualifications Clinical research coordination, screening, enrolling, and regulatory knowledge. RedCap and various clinical databases proficiency. Clinical Research certification by SOCRA or ACRP preferred. Associates or Bachelor’s degree in a clinical or scientific field, or clinical certificate/license with 3+ years of clinical research experience required. Cardiology experience preferred.