Based in Mountain View, CA., NeuroPace is a commercial-stage medical device company focused on transforming the lives of people suffering from epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differential RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source.
At NeuroPace, employees are our greatest asset. We are continually searching for solution-oriented individuals who can bring energy and creativity to our growing workforce. At NeuroPace, our success depends upon our ability to recruit and retain the most talented, enthusiastic and dedicated people we can find and providing them with a dynamic and challenging environment in which to thrive.
We are currently seeking a Sr. Clinical Study Coordinator to 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.
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: Bachelor's 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%).
$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.
Fraud Alert: We're aware of fake job postings using NeuroPace's name. Legitimate communications only come from @neuropace.com emails and never request personal financial info or other personal data upfront. Please verify suspicious messages by contacting us directly. View our current job openings: https://www.neuropace.com/about-neuropace/neuropace-careers/
Benefits
- Medical, Dental & Vision Insurance
- Voluntary Life
- 401K
- RSU
- 529 plan
- ESPP Program
- Health & Wellness Program
- Generous Paid Time Off plus eleven paid holidays
- FSA & Commuter Benefits
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)
PRIVACY NOTICE: NeuroPace takes its responsibility to protect your personal information seriously, and it uses reasonable safeguards to avoid unauthorized use or disclosure of it, and inadvertent loss or impermissible alteration of it. NeuroPace complies with all applicable federal and state laws and regulations that govern the handling of your personal information. If you would like more detailed information on NeuroPace’s privacy policies, please refer to neuropace.com/privacy/ for reference. NeuroPace retains candidate resumes and applications in its files for future reference and/or consideration for other available job postings. If you do not wish for your resume and applications materials to be retained in NeuroPace files, or wish to obtain a listing of any personal information that NeuroPace has stored about you, please contact us at privacy@neuropace.com.