Clinical Research Associate

Summary

Join our Clinical Team as a Clinical Research Associate and play a crucial role in pioneering groundbreaking clinical studies, contributing to the planning, execution, and success of innovative trials.

Requirements

• Bachelor's degree in life sciences or related field
• Minimum of 5 years of experience working in clinical trials with 3 years as a Clinical Research Associate
• Strong understanding of GCP, FDA, and ICH guidelines, regulations, and compliance requirements (e.g., 21 CFR 812, ISO14155)
• Proven ability to manage multiple tasks, prioritize workload effectively, and meet deadlines in a fast-paced environment
• Excellent interpersonal, communication, and organizational skills
• Ability to travel domestically and internationally, as required, up to 50%

Responsibilities

• Conducting qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocols and applicable regulations
• Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff
• Verifying medical record and source documentation against case report form (CRF) data, including informing the site staff of any entry errors, ensuring good documentation (GDP) practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements
• On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward
• Assisting in regulatory document write-up and reviews
• Organizing and submitting IRB/EC submissions and applicable regulatory documentation with follow-through to ensure successful outcomes
• Amending clinical study documents (ICF, CRFs, Monitoring Plan, etc…) as needed and helping clinical sites with institutional review board submission as necessary
• Reviewing and verifying adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with protocol
• Assessing the clinical research site's patient recruitment and retention success and offering suggestions for improvement as well as helping with Sponsor recruitment activities
• Completing monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance
• Contributing to the review of consent form language for consistency across protocols

Preferred Qualifications

• Advanced degree in life sciences or related field
• Significant experience in medical device studies
• Certification as a Clinical Research Professional (CCRP) or equivalent
• Proficiency in Microsoft Office Suite and familiarity with electronic data capture (EDC) systems
• Experience working in a fast-paced medical device startup environment
• Experience working in neuromodulation, surgical robotics, or another Class III implantable device

Benefits

• Excellent medical, dental, and vision insurance through a PPO plan
• Paid holidays
• Commuter benefits
• Meals provided
• Equity + 401(k) plan *Temporary Employees & Interns excluded
• Parental leave *Temporary Employees & Interns excluded
• Flexible time off *Temporary Employees & Interns excluded