Clinical Operations Associate

Clinical Operations Associate

At BioFire Defense, our workplace is as vibrant as our mission: casual vibes, intense execution, and a passion for IMPACT.

The Clinical Operations Associate supports the execution of clinical studies by ensuring compliance with company policies, BioFire Defense's Quality Management System, Good Clinical Practices, and applicable regulatory standards, while assisting with SOP/WID updates and regulatory guidance reviews. This role assists Clinical Affairs group with study logistics, including supply management, shipment coordination/execution, budget support, maintaining the electronic Trial Master File, as well as data verification and monitoring activities. They will assist the team with Biosafety Level 2 laboratory work such as managing clinical specimen inventory and in-house clinical studies while adhering to safety protocols and accurate documentation practices. The position involves routine problem-solving within established procedures, cross-functional collaboration, occasional communication with clinical sites, and additional administrative responsibilities as assigned. The Clinical Operations Associate exhibits strong communication, organization, and attention to detail.

Primary Duties

Compliance and Quality: Perform all work in compliance with company policies and BioFire Defense's Quality Management System. Support Quality compliance by formatting, revising, and editing relevant SOPs/WIDs. Support Regulatory compliance by reviewing and summarizing relevant regulatory guidance and standards. Draft study documents in compliance with Good Clinical Practices (GCP).

Clinical Study Support: Assist Clinical Affairs group with daily operations of clinical studies and contribute to ongoing monitoring activities. Prepare study supplies for clinical sites and coordinate clinical study shipments to and from clinical sites. Support management of the electronic Trial Master File (eTMF) and other internal tracking documents.

Data Management: Support Clinical Affairs group with data management activities including data verification for clinical and regulatory studies, review of electronic case report forms and run files. Support development, maintenance, and/or validation of data management tools (R, Python, Microsoft Products).

Specimen Management: Work in a Biosafety Level 2 environment with potentially pathogenic microbes, clinical specimens, and body fluids. Support maintenance of the clinical specimen inventory through internal spreadsheets and Laboratory Information Management System (LIMS).

Qualifications

Training, Education, and Experience:

• Bachelor's degree in scientific discipline.
• 1-2 years' of project or clinical study coordination, or other related experience, preferred.

Skills:

• Strong written and verbal communication skills with an emphasis in technical writing.
• Ability to work effectively with multiple disciplines and personalities.
• Self-starter, with the ability to work and learn independently.
• Attention to detail is fundamental to this position.
• Ability to accurately follow written and verbal instructions.
• Basic knowledge of Microsoft Excel and Word.
• Strong organizational, time management, and administrative skills.

Physical Requirements and Role-Based Expectations:

• Must be comfortable working with Biosafety Level 2 pathogens.
• Must be comfortable working with human specimens and bodily fluids (blood, saliva, sputum, etc.).
• Manual and visual dexterity to handle small tubes and manipulate very small volumes; reasonable accommodations are applicable.
• Must be able to wear personal protective equipment, including disposable gloves, facemask, and safety glasses, as needed.
• Must be comfortable working with cleaning products such as bleach.
• Must maintain regular and consistent on-site attendance.
• Must be able to safely lift and maneuver 40lbs.

Compensation will be determined based on the candidate's experience, skills, and qualifications.

Benefits:

Medical

Dental

Vision

Bonus eligible

9/8/80 work schedule (every other Friday off)

401k - company match of 5% regardless of participation and up to a total of 9.5% company match if contributing

160 Hours of PTO (prorated from date of hire)

9 Paid Holidays

Paid Winter Break from the work week between December 24 thru December 31

Participation in Company's Wellness Program (discounted medical premiums)

Multiple Company Sponsored Events Each Year (catered breakfast/lunch, holiday parties, snacks)

Convenient location near I-15 and Trax Station

Free Parking

Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.