Sr. Clinical Study Coordinator

We are currently seeking a Sr. Clinical Study Coordinatorto join our team. This individual will be responsible for day-to-day senior level administrative and project activities for Clinical department overseeing numerous multi-center clinical trials and will Independently manage complex study coordination tasks. This position is a remote position with minimal travel required. Desired home base location is Minneapolis MN.

Primary Responsibilities:

Takes ownership of TMF quality completeness and inspection readiness for assigned studies; performs QC reviews; proactively identifies documentation issues.

• Performs thorough quality checks on essential documents; assists in audit/inspection preparation
• Handles more complex studies or higher volume with minimal supervision; independently manages assigned documentation and coordination tasks.
• Communicates proactively with cross-functional teams; serves as a primary point of contact for TMF/documentation inquiries
• Identifies risks related to documentation quality or timelines; troubleshoots and proposes solutions for documentation/TMF issues.
• Manages own workload; develops and maintains study documentation trackers; may contribute to planning specific administrative/documentation timelines.
• Coordinates activities with study specific committees vendor services and core labs.
• Provide oversight and quality control of our internal regulatory filing system
• Manage study supplies
• Coordinate project meetings and assist in producing quality meeting minutes.

Required Qualifications:

• Education: Bachelors Degree preferred; Associate Degree with equivalent relevant experience considered. A degree in a Life Science field is preferred.
• Experience: Minimum 3-5 years relevant experience (e.g. Clinical Study Coordinator CRA Assistant TMF Specialist).
• Regulatory Knowledge: Strong understanding and application of GCP/ICH;

Key Skills and Competencies:

• Demonstrated proficiency with eTMF systems required. Strong skills in CTMS EDC systems and Microsoft Office Suite.
• Good working knowledge of medical and clinical terminology within assigned therapeutic areas.
• Strong communication skills (written and verbal).
• Excellent organizational skills and attention to detail.
• Ability to work independently and manage assigned tasks effectively.

Travel Requirements:

• Minimal travel required (e.g. up to 0-10%).

#LI-Remote

$85K Base - Compensation will be determined based on several factors including but not limited to skill set years of experience and geographic location.

NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

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NeuroPace is proud to be an equal opportunity employer and values the contributions of our culturally diverse workforce.

San Francisco and Los Angeles applicants: The Company will consider for employment qualified applicants with Criminal Histories in a manner consistent with the requirements of the Los Angeles Fair Chance in Hiring Ordinance or the San Francisco Fair Chance Ordinance (as applicable)

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