Clinical Research Laboratory Assistant [Bilingual]
About the role
The Clinical Research Laboratory Assistant is responsible for collecting, preparing, and processing patient samples for testing 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.
Responsibilities
- Conduct and coordinate patient visits in accordance with study protocols.
- Perform clinical tasks such as vital signs, ECGs, specimen collection/processing, and phlebotomy.
- Process samples for testing including centrifugation, storage, and shipping.
- 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.
Requirements
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.
Qualifications
A high school diploma required, bachelor’s degree in related field preferred. Lab experience required. Experience with patient-facing activities (phlebotomy, vital signs, EKGs, etc.) required. Clinical research experience preferred.
Skills
- Phlebotomy
- Specimen Processing
- Vital Signs
- ECG
- ICH/GCP Guidelines
- Medical Terminology
- EDC
- CTMS
- Patient Communication
- Data Integrity
- Microsoft Office
- Clinical Research Industry
- Biotechnology Research