Position Summary:
The Clinical Research Coordinator is responsible for coordinating and executing ophthalmology 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.
- Current MA certification or nursing licensure (LPN, RN) preferred.
Work Schedule: Monday-Thursday 8:00AM-5:00PM, Friday 8:00AM-1:00PM, optional weekends/overnights