Clinical Research Associate I

Description

A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

In North America we have more than 5,000 team members across 11 sites or subsidiaries, including Salt Lake City-based BioFire Diagnostics and one subsidiary in Montreal, Canada.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Job Summary

The Clinical Research Associate I (CRA) works under the supervision of a Manager, Clinical Research Scientist to manage clinical studies conducted by BioMerieux The CRA I is the primary liaison between BioMerieux 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. The CRA I may contribute to laboratory procedures that describe activities at study sites for the performance of clinical studies.

Essential Job Duties and Responsibilities

1. Perform all work in compliance with company policy and within the guidelines of BioMerieux’s Quality System.
2. Responsible for working with the Manager, Clinical Research Scientist for coordination and management during BioMerieux’s clinical studies. The CRA is BioMerieux’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 protocol
   • Providing logistical, technical, and regulatory support to both BioMerieux 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 Comparator Testing team or other external reference laboratories, as needed
   • Coordinate with Data Specialists to resolve data discrepancies, initiate queries, and ensure sites act promptly to address them, as needed
3. Performs related lab duties, as needed.
4. Contributes to project process within his/her scientific discipline.
5. May participate in scientific conferences and contribute to scientific journals.
6. Maintains current knowledge of IHC/Good Clinical Practices.
7. Maintains current training in Human Subjects Protections through an accredited program (e.g. CITI).

Supplemental Data

• 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 staff , etc) involved in conducting the clinical studies.
• The ability to work closely with Manager, Clinical Research Scientist to identify and communicate areas of technical, schedule, and budget risk.
• Excellent organizational skills are essential.
• Some driving within Salt Lake County may be required. Must provide own transportation.
• Domestic and international travel required – up to 30%.
• May require some non-standard work hours in order to maintain effective communications with various national and international study sites.
• Flexible scheduling (including some work form home) at the discretion of supervisor and within the company policy.

Qualifications

Training and Education
Minimum of a Bachelor’s degree in Biology, Microbiology, or related field.

Experience
2 years of experience with molecular biology laboratory techniques, including PCR. Prior experience with human subjects testing/research is preferred.

Knowledge, Skills and Abilities
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.

Physical Requirements
Lift up to 60 lbs.
Regular and consistent attendance.