Clinical Research Associate- Hourly

About Gregor Diagnostics

Gregor Diagnostics Inc. is a Madison, WI based, venture-backed, molecular diagnostics company developing novel molecular diagnostics for improved prostate cancer detection and patient management.

Summary of Major Responsibilities

The Clinical Research Associate (CRA) will be involved inaspects of sponsor clinical trial development and maintenance at Gregor
Diagnostics. The CRA will work directly with sites, CROs, and other contracted groups to manage day-to-day aspects of current and future clinical trials. The CRA will report to the Director of Clinical and Regulatory at Gregor.
 

Essential Duties and Responsibilities

1. Maintain shipping of site supplies andsample tracking.
2. Assist in the data migration from old databases into the REDCap database.
3. Participate in ongoing review of data in REDCap database to ensure quality and consistency.
4. Assist in thecoordination of clinical operations required to initiate, execute, and complete clinical trials to drive on time delivery of clinical trial milestones.
5. Maintain relevant clinical documents as part of Trial Master File including study protocols, data collection documents, regulatory compliance documents, training documents, and documents detailing standard operating procedures.
6. Maintain communication between the sponsor, CRO, and sites.
7. Manage data in the clinical and safety databases.
8. Communicate timely, appropriate, project information to project teams, sites and company.
9. Participate in the development of integrated clinical study reports to ensure accuracy, scientific excellence, and congruence of message between studies within a project.
10. Other duties as assigned.
    

Qualifications

Education and industry experience:

• Bachelor’s degree preferred in Life Sciences or related field.  
• Strong working knowledge of clinical trial management, clinical operations, study enrollment, database management, and study planning.
• Experience working with clinical databases, EDC systems, and reporting; Experience in REDCap preferred. 
• Understanding of IRB processes, submissions, and requirements. 
• Industry sponsor experience: In vitro diagnostics (IVD) and/or medical device sponsor(s) strongly preferred. 
• Clinical or research experience in oncology, ideally in diagnostic product development. 
• Strong verbal and written communication skills, including documentation and regulatory compliance. 
• Strong analytical, problem-solving, and decision-making skills. 
• Ability to work in a team environment and adapt to changing plans and circumstances.

Physical Requirements

• Ability to work for up to 8 hours a day in an office environment.
• Ability to work up to 6 hours a day in a laboratory environment.
• Ability to lift and move up to 40 pounds on an occasional basis.

Please submit to: careers@gregordiagnostics.com

Gregor Diagnostics is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state, or federal law.