Clinical Research Associate I

Reports To: Sr. Manager, CA Site Ops

Position Summary

The Clinical Research Associate I (CRA) works in parallel with Clinical Trial Managers to manage clinical studies conducted by bioMérieux. The CRA is the primary liaison between bioMérieux and clinical study site personnel for logistical coordination and first line troubleshooting. The CRA helps to ensure that all aspects of clinical studies are performed in accordance with the applicable regulatory requirements and study protocol. The CRA contributes to study procedures that describe activities at study sites for the performance of clinical studies.

Primary Duties

1. Perform all work under close supervision in compliance with company quality procedures and standards.
2. Work closely with the Clinical Trial Managers for coordination and management of bioMérieux’s clinical studies: communication with clinical study sites, confirmation that study testing follows the study protocol, remote (real-time) and on-site monitoring study site activities to ensure study compliance.
3. Coordinate shipping and receiving of specimens from study sites to the in-house Lab Operations team or other external reference laboratories, as needed.
4. Coordinate with Data Management and Clinical Trial Managers to resolve data discrepancies, initiate queries, and ensure sites act promptly to address them, as needed.
5. 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.
6. Performs related lab duties, as needed.
7. Contributes to project process within his/her scientific discipline and may participate in scientific conferences.
8. Develops and maintains knowledge of IHC/Good Clinical Practices and current training in Human Subjects Protections through an accredited program (e.g. CITI).
9. Contribute, under close supervision, to study procedures and final study reports.
10. Coordinate with Data Management to resolve data discrepancies, initiate queries, and ensure sites respond promptly to all emergent study issues address these issues, as needed.

Qualifications

Required Education, Training and Experience

• Bachelor degree required.
  • Microbiology, Molecular Biology, Life Sciences, Biomedical, or related field.
• No previous experience required.

Preferred Education, Training and Experience

• Experience with clinical study monitoring.
• At least 2 years of hands-on experience with immunology, microbiology, and/or molecular biology laboratory techniques (may be demonstrated from experience during bachelor's degree).
• Prior experience with human subject's testing/research.
• Proven ability to independently manage projects, identify risks, and report on progress.

Knowledge, Skills, and Abilities

• Consistently upholds and reflects the core ethical principles and values that bioMérieux promotes.
• Effective verbal communication skills.
• Ability to work cross-functionally allowing for better collaboration and communication when working across teams to achieve shared objectives.
• Communicates instructions clearly and effectively.
• Practicing time management to allocate tasks, balance priorities, and meet deadlines efficiently.
• Participate in a way that enhances team performance and cohesion.
• Skilled in MS Office tools to include but not limited to Outlook, Teams, Word, and Excel.
  • Intermediate: applies skills independently in most situations; handles moderately complex tasks with occasional guidance.
• Demonstrated Scientific/Technical writing skills.

Additional Information

Supervisory Responsibilities (Not applicable).

Supplemental Information

• This position requires excellent written and oral communication skills.
• Excellent interpersonal skills and the ability work with a wide variety of people (physicians, laboratory directors, laboratory/hospital staff, etc.) involved in conducting the clinical studies.
• The ability to work closely with Management and Clinical Trial Managers to identify and communicate areas of technical, schedule, and budget risk.
• Excellent organizational, technical, and problem-solving skills are essential.
• Some local driving within the region may be required. Must provide own transportation.
• Domestic and international travel required – up to 30%.
• May require some non-standard work hours to maintain effective communications with various national and international study sites.
• Flexible scheduling (including some work from home) at the discretion of management and within the company policy.

Working Conditions and Physical Requirements

• Ability to remain in stationary position, either sitting or standing, for prolonged periods: Yes.
• Ability to ascend/descend stairs, ladders, ramps, and the like: Yes.
• Ability to wear PPE correctly most of the day: No.
• Ability to operate heavy machinery: No.
• Ability to adjust or move objects up to 50 pounds in all directions: Yes.
• Domestic travel required: 25%.
• International travel required: 5%.
• Total travel required: 30%.
• On-site position (Hybrid schedule 50% on -site)