Clinical Research Associate (New Health Care Company)

Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Job Title

Clinical Research Associate (New Health Care Company)

3M is establishing two industry-leading companies, creating value through the spin-off of its Health Care business, while 3M will continue to be a global material science leader, focusing our innovation to win in favorable global megatrends and attractive end markets. This new Health Care Company will be a leading global diversified health technology company with:     

• Proven category leadership  
• Exposure to attractive end-markets  
• Innovation mindset driving improved patient outcomes  
• Collaborative customer relationships  
• Deep global regulatory experience  
• Operational excellence and strong cash flow  
• Strong sales growth and profitability with significant recurring sales  

We expect the creation of the two companies will be completed by the end of the first quarter of 2024. We will continue to operate as one global company. This role is positioned to drive the success of the "New Health Care Company”.  

The Impact You’ll Make in this Role

As a Clinical Research Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

• Ensuring preparation, collection, and distribution of trial master file (TMF) documents and maintenance of regulatory files at investigative site
• Conducting pre-study site visits, collecting and reviewing site feasibility and operational processes information, and preparing reports; participating in the final selection of investigators and study sites
• Conducting clinical study site initiation visits; advising and training site personnel on Sponsor and regulatory requirements for study conduct
• Conducting site monitoring visits and following-up to identify significant problems and issues and ensuring that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies
• Reviewing on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifying deficiencies and discrepancies, and providing remedial training and/or initiating corrective action as required
• Reviewing case report form queries and problems, and clarifying and/or obtaining changes to data as appropriate
• Collaborating closely with the Clinical Project Manager, cross functional study teams and all Research partners, internal and external to company
• Assisting with device preparation, shipment coordination and maintaining appropriate accountability records

Your Skills and Expertise 
To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

• Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution AND Five (5) years of recent clinical research-related study monitoring experience (large multi-site, regulated trials i.e. IDE, medical device industry) in a private, public, government or military environment.

OR

• High School Diploma/GED (completed and verified prior to start) AND 7 years of clinical research, biomedical, or medical device industry experience in a private, public, government or military environment which must include at least 5 years of study monitoring experience.

Additional qualifications that could help you succeed even further in this role include:

• Experience working in hospital or clinical setting or medical laboratory
• Having experience working in critical care medicine.
• Clinical research certification by SoCRA or ACRP.<