Clinical Research Associate

This person is the point of contact for assigned clinical investigation sites during the start-up, conduct and closure of clinical trials. Responsible for on-site and remote site monitoring visits including qualification, site initiation, interim monitoring, and site close-out. Supports cross-functional team members throughout the full product lifecycle.

Job Duties:

• Performs monitoring by comparing case report forms against medical records and source documentation. Creates and closes queries as necessary.
• Reviews and collects essential documents from clinical investigation sites. Files documents in the Trial Master File (TMF).
• Writes monitoring reports and submits for review and sign-off, tracks event and deviation reporting according to the monitoring plan.
• Responds to site questions and resolves compliance issues during the conduct of clinical investigations, or escalates to appropriate team member(s) as needed.
• Inspects the Trial Master File (TMF) to ensure collection and maintenance of site essential documentation is properly filed.
• Trains investigation site personnel.
• Provides input on project-specific plans.
• Collaborates with field clinical team members.
• Performs IP and equipment accountability tasks.
• Participates in site start-up activities.
• Creates documentation to support the operations of studies.
• Supports cross-functional activities as needed.

Skills & Qualifications

Required

• Bachelor’s degree, scientific field preferred
• Medical Device clinical investigation experience
• Minimum 3 years of clinical trial experience
• Understanding of clinical investigation monitoring
• Experience working under standard operating procedures
• Knowledge of Good Clinical Practice and FDA medical device regulations
• Strong attention to detail
• Ability to problem solve and use critical thinking
• Proficient oral and written communication
• Proficiency in MS Word, MS Excel and MS Outlook

Preferred

• Class III medical device experience
• Experience with Sponsor managed, FDA regulated, clinical trials
• Certification by ACRP, SOCRA or similar organization
• Knowledge of EU Medical Device Regulations
• Ability to work hybrid remote schedule and report to office in White Bear Lake, MN

Travel requirements: Travel up to 80%

Other requirements: Ability to enter health care facilities based upon the institution’s vaccination/ policy requirements

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Application Question(s):

• What makes you interested in this role?
• Optional: Provide your LinkedIn profile URL

Ability to Commute:

• Saint Paul, MN 55110 (Preferred)

Work Location: Hybrid remote in Saint Paul, MN 55110