Position Summary:

The Clinical Research Assistant 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:

• Conduct and coordinate patient visits in accordance with study protocols.
• Perform clinical tasks such as vital signs, ECGs, specimen collection/processing, and phlebotomy (as applicable).
• Ensure informed consent is properly obtained and documented.
• Educate and guide participants throughout 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/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.

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.
• 0-1 years of clinical research experience.
• Experience with patient-facing activities (phlebotomy, vital signs, EKGs, etc.) required.
• Phlebotomy or Medical Assistant certification preferred.