Overcoming the limitations of conventional CRT through Wireless, LV Endocardial Pacing
Senior Clinical Research Associate
Location
United States
Posted
21 days ago
Salary
$108.7K - $139.8K / year
Seniority
Senior
Job Description
Senior Clinical Research Associate
EBR Systems, Inc.
• The Senior Clinical Research Associate is accountable for monitoring excellence, data integrity, and site engagement across the full lifecycle of a clinical study. • Ensure studies are conducted compliantly, data are reliable, and sites are operationally and clinically supported from start-up through close-out. • Actively support enrollment and follow-up performance, and engage with site teams on the clinical substance of the work. • Collaborate with internal clinical teams in the execution of the study to achieve study goals and milestones. • Monitor subject enrollment progress across assigned clinical study sites to ensure enrollment targets and timelines are met.
Job Requirements
- Bachelor's degree in life sciences, nursing, biomedical or electrical engineering, or a related scientific or technical field preferred; an equivalent combination of education and professional experience is acceptable.
- Five or more years of experience in the medical device industry required.
- Five or more years of CRA experience on complex IDE or PMA studies, with at least two years in a medical device setting, or an equivalent combination of CRA and relevant clinical experience such as Study Coordinator, cardiac device clinic, or Field Clinical Engineering.
- Class III cardiovascular rhythm management (CRM) device experience (e.g., pacemakers, ICDs, CRT-D) or equivalent implantable cardiovascular device experience is strongly preferred.
- Strong expertise in clinical trial management (medical device preferred) and the CRA role and responsibilities.
- Knowledge of regulatory standards (ICH, GCDMP, 21 CFR 11, GDPR)
- Experience with web-based EDC, software tools (Microsoft Office Suite), Adobe, SharePoint, shared drive, and other custom web-based software used for administrative functions.
- Willing and able to travel up to 30%, which may include weekend and overnight trips when appropriate.
Benefits
- Medical, dental, and vision insurance provided at no cost for employee-only coverage
- 401(k) matching plan
- Paid Time Off – starting at 3 weeks per year
- Competitive salary with opportunities for career growth
- Employee stock options
- Life & AD&D and long-term disability insurance
- Education assistance
- Voluntary commuter benefits and pet insurance
- Meaningful work and much more!
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Research Forensic Data Analyst
Mass General BrighamMass General Brigham connects a full spectrum of care across a system of academic medical centers, specialty and community hospitals, physician networks, a heal
Title: Research Forensic Data Analyst Location: 399 Revolution Drive Somerville (Assembly Row Main Building) Job Description: Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for conducting complex investigations, audits, and regulatory reviews across the research enterprise. This role provides expert oversight of research risks, financial stewardship, adherence to policies, and compliance with federal, state, sponsor, and institutional requirements. The position will partner closely with Research Operations, Office of General Counsel, HR, Research Management, Internal Audit, and other research support departments to mitigate risk, strengthen controls, and uphold institutional standards of conduct. Essential Functions -Conduct confidential investigations involving professional misconduct, financial improprieties, authorship disputes, data integrity concerns, and allegations of violations of institutional policy. -Collect and analyze evidence, including documents, digital records, interviews, financial data, and research documentation. -Prepare investigative reports for internal stakeholders and regulatory bodies; present findings to MGB Chief Research Compliance Officer and other senior leaders or oversight committees. -Review sponsored project activity for compliance with agency guidelines, allowable cost principles, grant terms, and institutional commitments. -Assess research programs for compliance with conflict of interest, effort commitments, sub-recipient monitoring, data management, and human/animal subject protections. -Partner with the offices of Research Management, Finance, Contracting, and Research Integrity to resolve compliance issues. -Participate in compliance risk assessments across research departments. -Advise leadership and investigators on leading practices for research oversight, internal controls, and risk mitigation. -Support training and education initiatives on audit readiness, regulatory expectations, and responsible conduct of research. Qualifications Education - Bachelor's Degree Related Field of Study required - Equivalent experience may be accepted in lieu of a degree Experience - Previous experience in research compliance, forensic auditing, investigations, or regulatory oversight in a healthcare, academic, or research institution 3-5 years required Knowledge, Skills and Abilities - Demonstrated authority partnering with cross-functional stakeholders and navigating highly sensitive investigations. - Proficient in analytical, writing, interviewing, and evidence evaluation skills. - High ethical standards with the ability to handle confidential matters. - Proficient investigative acumen and critical thinking skills. - Advanced knowledge of research regulations (NIH Grants Policy Statement, Uniform Guidance 2 CFR 200, PHS COI, FDA, etc.). - Excellent communication skills, including the ability to draft clear findings and articulate complex issues to executives - Ability to manage multiple complex cases simultaneously under tight deadlines. 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ISD's Guiding Principles ofintegrity, collaboration,agility andcouragedefine who we are as a team and an organization. These principles reflect our culture and guide the way we work and the choices we make. ISD is not your ordinary think tank. We turn research into action that changes the world. Our insights don't gather dust on shelves - they power the fight to protect democracy and human rights on the front lines. We're committed to delivering real change, from the grassroots to the highest levels of global institutions. And we're looking for passionate individuals who share our commitment to making a difference. Join us and be part of an organization that's making an impact. 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