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. As a subject/patient-facing position, strong communication skills are essential for collecting detailed clinical information and sharing it with the study team. The coordinator will be responsible for all aspects of trial conduct, including IRB submission, regulatory documentation, staff training, and overseeing subject enrollment.

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.
• Oversee the ordering, receipt, and maintenance of study supplies.
• Communicate regular study updates with administration.
• Oversee clinic activities as assigned.
• Perform clinical activities as experience and delegation allow.
• Perform on-call duties during evenings and weekends as assigned.

Essential Skills

• Clinical research coordination, screening, enrolling, and regulatory knowledge.
• Proficiency in Microsoft Office products, including Excel.
• Experience with clinical documentation and HIPAA guidelines.
• RedCap and various clinical databases proficiency.
• 5+ years of clinical research experience

Additional Skills & Qualifications

• Associates or Bachelor’s degree in a clinical or scientific field, or clinical certificate/license
• Cardiology experience preferred
• Clinical skills, including phlebotomy, ability to take and record accurate vital signs, obtain EKG tracings, and familiarity with medical terminology preferred.
• Clinical Research certification by SoCRA or ACRP.

Work Environment

This position operates in an office environment, interacting with clinical research patients for screening, consenting, and enrolling in clinical trials. The role requires flexible availability and may involve on-call duties during evenings and weekends.