Clinical Research Coordinator

Job Description

We are seeking a dedicated Clinical Research Coordinator 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.