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.
1-3+ years of clinical research experience.
Experience with patient-facing activities (phlebotomy, vital signs, EKGs, etc.) strongly preferred.

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