What are the responsibilities and job description for the Clinical Research Associate I position at bioMerieux SA?
Description
The Clinical Research Associate I (CRA) works in parallel with Clinical Scientists to manage clinical studies conducted by bioMérieux. The CRA I is the primary liaison between bioMérieux and clinical study site personnel. The CRA I helps to ensure that all aspects of clinical studies are performed in accordance with the applicable regulatory requirements and study protocol. The CRA I contributes to laboratory procedures that describe activities at study sites for the performance of clinical studies.
Job Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of bioMérieux’s Quality System.
- Responsible for working with the Clinical Scientist for coordination and management of bioMérieux’s clinical studies. The CRA is bioMérieux’s liaison with regards to the studies and is responsible for:
- Communication with clinical study sites
- Remote and on-site monitoring study site activities to ensure study compliance.
- Confirmation that laboratory testing follows the study protocol.
- Providing logistical, technical, and regulatory support to both bioMérieux and study site personnel to ensure that all parties have the necessary equipment, training, and materials to fulfill their role in the studies.
- Maintenance of study tracking documents
- Contribute to study procedures and final study reports.
- Real-time monitoring/management of site inventory/supplies to ensure sufficient resources are available to avoid study interruptions.
- Coordinate shipping and receiving of specimens from study sites to the in-house Lab Operations team or other external reference laboratories, as needed.
- Coordinate with Data Management and Clinical Scientist to resolve data discrepancies, initiate queries, and ensure sites act promptly to address them, as needed.
- Performs related lab duties, as needed.
- Contributes to project process within his/her scientific discipline.
- May participate in scientific conferences.
- Maintains current knowledge of IHC/Good Clinical Practices.
- Maintains current training in Human Subjects Protections through an accredited program (e.g. CITI)
Domestic and international travel required – up to 30%.
Minimum Qualifications:
- Bachelor’s degree in biology or healthcare related field.
- 2 years of experience with immunoassay laboratory techniques.
- Prior experience with human subjects testing/research is preferred
- Strong computer skills required including word processing and use of spreadsheets.
- Skills with database and project management software desirable.
- Demonstrated ability to independently manage projects and report areas of risk as they arise.
- Demonstrated Scientific/Technical writing skills.
