Senior Clinical Research Associate

About ReCor MedicalAt ReCor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.
Position SummaryThe Senior Clinical Research Associate (Sr. CRA) is responsible for monitoring protocol adherence, regulatory compliance, patient safety, and data quality.

Responsibilities and Duties

• Mentors junior team members, as needed, including on-boarding and training related to core responsibilities.
• Participates in and may lead regular monitoring team meetings to share best practices, identify process improvements, and create consistency across monitoring team.
• Supports the evaluation of clinical sites for possible participation in ReCor projects.
• Supports site qualification and initiation visits and ad-hoc trainings of site team members, as needed.
• Schedules, prepares for, and conducts interim monitoring visits and close-out visits.
• Monitors study data and verifies source documentation for accuracy and completeness.
• Collaborates with sites and cross-functional teams to resolve data queries.
• Collaborates with study team to develop project related documents, as needed.
• Completes monitoring reports and associated communications in compliance with Monitoring Plan and SOPs
• Responsible for device accountability at each site visit throughout the study.
• Reviews and maintains the Investigator Site File/Regulatory Binder and collects documents for Sponsor files.
• Facilitates submissions to Ethics Committees/Institutional Review Boards (IEC/IRB), and regulatory authorities, as needed.
• Continuously assesses institutional, regulatory and clinical protocol compliance.
• Complies with Data Protection (GDPR, HIPAA), Good Clinical Practice (ISO14155), relevant local laws and regulations, SOPs, WIs, clinical protocols, and Manual of Operations.
• Identifies and escalates non-compliance and project related risks, as needed. 
• Participates in project team meetings, escalates risks and issues, and represents monitoring function as needed.
• Supports activities related to site audits and/or regulatory inspections.
• Collaborates with global and cross-functional team members to problem solve, share best-practices and provide input on process improvement initiatives.
• Other duties as assigned

Requirements

• Bachelor’s Degree or international equivalent in medical or scientific related discipline preferred.
• Minimum of 5 years monitoring related experience.
• Experience in medical device trials preferred.
• Clinical Research Associate certification preferred.
• Strong attention to detail and organizational skills.
• Excellent presentation, verbal, and written communication skills.
• Technical expertise including Teams, Word, Excel, eTMF and CTMS preferred.

COVID-19 vaccination requirementsAt ReCor Medical, we care, we collaborate, we challenge, and we create.  Pursuant to these core values, we are focused on the health and safety of our employees, as well as the teamwork essential for innovation of our pioneering technology. COVID19 vaccines are required for all ReCor US office employees effective June 10, 2021, as well as all new US office employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the recommended series of an FDA-authorized COVID-19 vaccine.  Equal Employment OpportunityAt ReCor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.