Contract Clinical Research Associate

Clinical/Research               ·              Minneapolis Minnesota             ·               Full time

Contract Clinical Research Associate

Minneapolis Minnesota

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 Contract Clinical Research Associate for the US to join our team. This individual will manage the operational activities at selected participating institutions for one or more US‐based IDE pre‐market clinical and post‐market investigations. The successful candidate will function as a key member of the clinical trial team, interacting closely with clinical trial managers, data management, and CRA colleagues. He/She will also oversee site evaluation, site initiation, training, study data and regulatory documentation monitoring, and close‐out activities in accordance with the protocol, company standard operating procedures, good clinical practices (GCP), and other applicable regulatory requirements. This position is a remote contract assignment; 12-24 months expected. The preferred location is the Central part of the United States.

Key Responsibilities

• Perform or assist in the ongoing training of site research staff.
• Conduct monitoring visits to review and assure the rights, welfare, and safety of study subjects are protected, and ensure integrity of clinical data with respect to accuracy, accountability, documentation, and adherence to procedures through review of eCRFs, source documents, medical records, and regulatory documents.
• Conduct co‐monitoring visits at investigational sites as needed.
• Compose timely monitoring visit reports.
• Collect, organize, and electronically submit essential clinical documents for the eTMF.
• Escalate issues to the study team in a timely manner.
• Collaborate with data management to ensure query resolution and support data cleaning.
• Support site audits and site audit preparation in anticipation of site inspections.
• Maintain a working knowledge of and assure compliance with the Good Clinical Practices, Federal Regulatory requirements, Risk‐Based Approach to Monitoring, and NeuroPace SOPs
• Perform other related duties incidental to the work described herein.

Requirements

• Bachelor’s or AA Degree in relevant life science field preferred.
• Minimum 5-7 years previous experience in a monitoring capacity.
• Experience managing medical device clinical studies, preferably neurostimulation experience.
• Ability to effectively communicate with professional medical personnel.
• Thorough knowledge of Good Clinical Practice (ISO 14155), 21 CFR part 50, 54, 56, 812 and other applicable regulations
• Strong time management, organization, interpersonal, verbal and written communication skills with a high degree of accuracy and attention to detail.
• Up to 80% domestic travel required

#LI-Remote

$80.00 hourly rate

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. 

Please click here to apply.