CRA 2

Custom Search Inc.; Minneapolis (MN); On-site; USD 70,000 - 95,000; Full time

Job summary

Custom Search Inc. is seeking a Clinical Research Associate II to advance post-FDA approval data collection for a medical device product. You will oversee site management, data integrity, and regulatory compliance across 8-20 U.S. sites, with regular travel.

The role emphasizes collaboration, training plan development, contract support, and support during external audits. A science/healthcare background and hands-on CRA experience are required.

Qualifications

• Bachelor's degree in science or healthcare (preferred).
• 1+ years of on-site clinical monitoring experience at a medical device company.
• 5+ years as a clinical research coordinator.
• Strong knowledge of ISO, GCP, ICH, FDA regulations.
• Experience with IDE studies and startup phases.
• Detail-oriented with ability to manage multiple priorities.
• Willingness to travel up to 50% and proximity to a major airport.

Responsibilities

• Oversee 8-20 clinical sites across the U.S., ensuring data integrity and regulatory compliance.
• Create and review clinical documentation; develop training plans for site personnel.
• Serve as primary contact for sites; guide qualification process and physician collaboration.
• Assist with contract negotiations with clinical sites.
• Travel 3-4 times per month in startup phase; 1-2 times per month thereafter to activate sites.
• Maintain TMF, ensure investigational device accountability, support external audits.
• Review adverse events and protocol data; assist with queries and DCF reviews.
• Participate in cross-functional meetings; prepare agendas and minutes; share best practices.

Skills

Detail-oriented

Multitasking

Travel readiness

Team collaboration

Education

Bachelor's degree

Tools

eTMF systems

Risk-based monitoring tools

IDE studies

Job description

Are you a highly motivated Clinical Research Associate looking to make a significant impact in a growing medical device company? Our start-up client is seeking a driven CRA 2 to join their Clinical Operations team and play a pivotal role in post-FDA-approval data collection for their innovative product. This is an exciting opportunity to contribute to a groundbreaking device that helps critically ill patients on mechanical ventilators breathe more effectively.

Your role with the company:

As a CRA, you will be instrumental in ensuring the successful execution of post-market clinical studies. Your responsibilities will include:

• Site Management: Oversee 8-20 clinical sites across the U.S., ensuring high-quality site management, data integrity, and regulatory compliance.

• Documentation & Training: Create and review clinical documentation, develop comprehensive training plans for site personnel, and verify adherence to protocols and regulations.

• Site Communication & Support: Act as a primary point of contact for sites, answering questions, guiding them through the qualification process, and collaborating with physicians.

• Contract Negotiation: Assist with the negotiation of contracts with clinical sites.

• Travel: Travel 3-4 times per month during the study startup phase, reducing to an average of 1-2 times per month thereafter, to activate sites and conduct on-site monitoring.

• Regulatory Compliance: Maintain the electronic Trial Master File (TMF), ensure investigational device accountability, and support quality teams during external audits.

• Data Oversight: Review and ensure timely reporting of adverse events, concomitant medications, and other protocol-required data, supporting query resolution and reviewing Data Clarification Forms (DCFs).

• Team Collaboration: Participate in cross-functional team meetings, prepare meeting agendas and minutes, and share best practices to contribute to continuous improvement initiatives within Clinical Operations.

Desired Profile:

• A Bachelor's degree (science or healthcare discipline preferred).

• 1+ years of dedicated clinical monitoring (on-site) experience at a medical device company.

• 5+ years of experience as a clinical research coordinator.

• Strong understanding of ISO, GCP, ICH, FDA, and other applicable clinical research regulations.

• Experience with IDE studies and involvement in startup phases.

• A detail-oriented, proactive approach with proven effectiveness in managing multiple priorities.

• Ability to travel up to 50% and close proximity to a major airport.

Preferred Qualifications:

• Experience in an ICU environment.

• Prior involvement with site monitoring and close-out activities.

• Familiarity with risk-based monitoring tools or eTMF systems.

• Experience mentoring junior staff.