The Clinical Research Laboratory 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.