Clinical Research Coordinator
About The Position
The Clinical Research Coordinator (CRC) coordinates and executes clinical trials in accordance with study protocols, ICH/GCP guidelines, sponsor requirements, and Rovia SOPs. The role partners closely with site teams to support study startup, enrollment, data quality, and overall study success. The CRC conducts patient visits, performs applicable clinical tasks, supports participants throughout the study, and monitors participant safety. The role also maintains accurate study documentation and data, manages investigational product accountability, and supports monitoring visits, audits, and inspections while collaborating with site staff and investigators to ensure protocol adherence and efficient visit flow.
Requirements
- High school diploma required.
- 1-3+ years of clinical research experience.
- 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.
Nice To Haves
- Bachelor’s degree in a related field preferred.
- Experience with patient-facing activities such as phlebotomy, vital signs, and EKGs strongly preferred.
Responsibilities
- Conduct and coordinate patient visits in accordance with study protocols.
- Perform clinical tasks such as vital signs, EKGs, specimen collection and processing, and phlebotomy as applicable.
- Ensure informed consent is properly obtained and documented.
- Educate and guide participants through the study, ensuring a positive patient experience.
- Monitor subject safety, report adverse events, and escalate concerns as appropriate.
- Complete timely and accurate source documentation and EDC data entry.
- Resolve data queries and ensure data integrity.
- Maintain investigational product accountability and proper storage and handling.
- Prepare for and support monitoring visits, audits, and inspections.
- Collaborate with site staff and investigators to ensure protocol adherence and efficient visit flow.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Education Level
High school or GED
