Position Summary:
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.
- 0-1 years of clinical research experience.
- Experience with patient-facing activities (phlebotomy, vital signs, EKGs, lab processing, etc.) required.
- Phlebotomy or Medical Assistant certification preferred.
- Current IATA certification preferred.
Position will require availability to start at 6:00AM.