Clinical Research Associate
NeoTract is a medical device company featuring a revolutionary technology called The UroLift® System. The UroLift® System treats BPH (benign prostatic hyperplasia) by lifting and holding the enlarged prostate tissue so it no longer blocks the urethra. Over 60,000 patients have been treated with UroLift® and we are currently seeking exceptional talent to grow our organization.
The Clinical Research Associate assists in developing and executing clinical studies from concept to the final clinical study report (CSR). As an integral member of the Clinical Affairs team, this position site manages and performs on-site monitoring in mutually exclusive studies, including investigational to post-market, one site to multi-site, and country randomized studies. This position is responsible for ensuring the quality, compliance, and timeliness of studies. This key position requires well-rounded on-site monitoring and in-house site management experience, the technical wherewithal to become proficient quickly in numerous electronic systems, and a strong passion for supporting best-in-class studies in a fast-paced, dynamic environment.
- Manage investigative sites by ensuring recruitment success, protocol, and regulatory compliance, as well as timely data discrepancy resolution while safeguarding the legal rights of subjects.
- Manage all functions involved in site launch, including site selection, contract coordination, ethics committee approval, device shipments, training, and site materials.
- Prepare for and conduct regular on-site initiation, interim, and close-out monitoring visits with timely report submission.
- Develop and execute clinical operations plans aligned with deadlines and department procedures.
- Support the clinical department initiatives, including optimizing SOPs and on-time internal training.
- Attain high-quality data and subject retention through proactive site management, including leading site webinars and writing newsletters.
- Maintain consistent and current trial master files.
- Collaborate with team members to write clinical study reports and report sections.
- Track and resolve site protocol deviations and action items, including reconciling device, equipment, imaging media disposition, and corrective action.
- Ensure adherence to Adverse Event/Serious AE/SAE reporting processes, and manage CEC charter activity and site queries.
- Collaborate with Data Management on data cleaning, media tracking, disbursement, and data analysis quality.
- Provide regular status reports or presentations to the team.
- Perform other duties as assigned.
- Contribute to our culture of being collaborative, respectful, transparent, ethical, efficient, high-achieving, and fun!
- Bachelor’s or RN degree; or equivalent work experience.
- Advanced degree preferred.
- At least 5 years of clinical research experience.
- Experience conducting on-site monitoring and in-house site management.
- Experience in the urology therapeutic area or medical device preferred.
- Ability to establish strong relationships with Research Coordinators, Clinical Affairs team, and cross-functional departments.
- Proficienct in Microsoft Word, Excel, and Access with the technical wherewithal to become proficient quickly in numerous other electronic systems.
- Strong knowledge of US and international clinical regulations and guidance.
- Ability to make independent decisions and take responsibility for own actions within a fast-moving environment.
- Ability to learn, optimize, achieve goals, and advance science.
- Ability to recognize potential obstacles, propose a solution, and work to resolve them within set timelines.
- Valid driver’s license issued by residing state and clean driving record.
- Ability to travel, up to 50%. Overnight travel is required. International travel is likely.