Clinical Studies Project Coordinator III

$52,400 - $78,600/Yr

AVE Medtronic Vascular Inc - Santa Rosa, CA

Full-time - Entry Level

Santa Rosa, CA

About the position

The Clinical Studies Project Coordinator III at Medtronic plays a crucial role in supporting the Mitral and Tricuspid Structural Heart clinical teams and studies. This position involves executing diverse administrative and project duties to ensure the successful coordination and management of clinical studies, contributing to healthcare access and equity.

Responsibilities

• Supports clinical studies by executing and maintaining data coordination, including development and testing of case report forms and study databases.
• Ensures timely and quality completion of data forms, verifies study data, and manages data discrepancies.
• Creates and manages clinical study files and oversees the organization and distribution of clinical study documents.
• Assists with periodic audits of clinical study files for completeness and accuracy.
• Provides project/program coordination and support to the Global Clinical Study team.
• Maintains study-specific correspondence and other required documentation.
• Assists in tracking study activity, ensuring receipt of proper study documentation, agreements, and site approvals.
• Coordinates meetings and meeting logistics, taking notes on discussion points and action items.
• Works with clinical teams to create and distribute newsletters and communications to sites.
• Monitors daily projects and contracts using various software tools, including Excel and SharePoint.
• Creates, runs, and monitors metrics and maintenance reports on an ongoing basis.
• Identifies issues in documents and recommends alternatives, executing actions when appropriate.
• Supports process improvement efforts to enhance systems and reduce lead time.
• Performs various study duties including facilities coordination, project document organization, and ordering supplies.

Requirements

• 4 years of administrative/project support experience
• High School Diploma or equivalent

Nice-to-haves

• Associate's or Bachelor's degree preferred
• Clinical research/study coordination experience at Medtronic or in the medical device industry
• Experience with Cardiovascular products/therapies
• Experience working with Siebel CTMS and Clinical RAD applications
• Knowledge of medical terminology
• Basic knowledge of GCP and regulatory compliance guidelines for clinical trials
• Proficiency in MS Office applications: Excel, PowerPoint, Word, Project (or similar scheduling software)
• Experience in a highly-matrix, dynamic, and fast-paced work environment
• Excellent written and verbal communication, and interpersonal skills
• Strong prioritization and organizational skills

Benefits

• Competitive Salary
• Flexible Benefits Package
• Wide range of benefits and resources
• Competitive compensation plans