Clinical Research Coordinator

Position Summary

The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical trials in accordance with study protocols, ICH/GCP guidelines, sponsor requirements, and Rovia SOPs. This role partners closely with site teams to support study startup, enrollment, data quality, and overall study success.

Key Responsibilities

• Conducts and coordinates patient visits in accordance with study protocols.
• Performs clinical tasks such as vital signs, EKGs, specimen collection and processing, and phlebotomy as applicable.
• Ensures informed consent is properly obtained and documented.
• Educates and guides participants through the study, ensuring a positive patient experience.
• Monitors subject safety, reports adverse events, and escalates concerns as appropriate.
• Completes timely and accurate source documentation and EDC data entry.
• Resolves data queries and ensures data integrity.
• Maintains investigational product accountability and proper storage and handling.
• Prepares for and supports monitoring visits, audits, and inspections.
• Collaborates with site staff and investigators to ensure protocol adherence and efficient visit flow.
• Perform other duties as assigned.

Skills/Abilities

• Strong knowledge of medical terminology and clinical procedures.
• Understanding of ICH/GCP and regulatory requirements.
• Excellent organizational skills and attention to detail.
• Strong interpersonal and patient-facing communication skills.
• Ability to multitask and manage competing priorities in a fast-paced environment.
• Proficiency in Microsoft Office, EDC, and CTMS applications.
• Ability to work both independently and collaboratively.
• High level of professionalism and commitment to patient confidentiality.

Education/Experience

• High school diploma required, bachelor’s degree in related field preferred.