Senior Clinical Research Associate

Senior Clinical Research Associate

The Senior Clinical Research Associate is a senior individual contributor and leader within the EBR Clinical organization, accountable for monitoring excellence, data integrity, and site engagement across the full lifecycle of a clinical study. The Senior CRA brings demonstrated clinical acumenor a strong capacity and drive to develop itand uses that knowledge to engage meaningfully with investigators, coordinators, and clinical events at the site level. Experience with Class III cardiovascular rhythm management (CRM) devices or equivalent implantable cardiovascular device experience is a core expectation of this role. The Senior CRA ensures studies are conducted compliantly, data are reliable, and sites are operationally and clinically supported from start-up through close-out.

Beyond traditional monitoring, the Senior CRA serves as a trusted clinical partner at the site levelcultivating strong investigator and coordinator relationships, actively supporting enrollment and follow-up performance, and engaging with site teams on the clinical substance of the work, not just operational logistics. The Senior CRA works in close collaboration with EBR Field Clinical Engineering, proactively removes barriers to study execution, interprets clinical data in context, and ensures issues are identified and escalated early to protect data quality, timelines, and regulatory outcomes. Studies are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements.

Essential Duties and Responsibilities

• Collaboratively work, build, and maintain effective working relationships cross-functionally with internal clinical teams in the execution of the study to achieve study goals and milestones.
• Regularly communicates with Study Manager and/or Clinical Director and other senior management regarding study status, identifying study gaps, issues, and risks.
• Assist in preparation of clinical study documentation such as study protocols, Informed Consent Form (ICF), training materials, monitoring, and safety plans etc., incorporating applicable regulatory guidelines study (i.e., ICH, GCDMP, 21 CFR 11, GDPR).
• Monitor subject enrollment progress across assigned clinical study sites to ensure enrollment targets and timelines are met.
• Maintain real-time enrollment trackers, dashboards, and study metrics; proactively identify trends, delays, or risk areas.
• Communicate regularly with site coordinators and investigators to assess screening activity, consent rates, screen failures, and enrollment barriers.
• Collaborate with the study team to forecast enrollment and adjust recruitment plans as needed.
• Prepare and deliver enrollment status updates for study meetings, monitoring reports, and site meetings as needed.
• Assess study operations and identify issues and risks that need action or elevation to senior staff.
• Work with research sites to execute the study according to protocol and regulatory guidelines.
• Effectively oversee site initiation, activation, patient enrollment, monitoring, and close-out activities; oversight would include that of CRAs contracted from an external Contract Research Organization (CRO) who are used to compliment the company's Clinical Department staff; co-monitors as required.
• Supports training of study teams including clinical study sites on clinical study systems such as protocol, electronic data capture (EDC), electronic trial master file (eTMF) systems, and CTMS (BSI).
• Ensure data completeness and integrity by monitoring study data to identify discrepancies and missing data via on-site or remote data monitoring.
• Identify, evaluate, and properly capture Adverse Events (AEs); ensure adequate follow-up, timely documentation and reporting according to internal procedures and regulatory requirements.
• Apply clinical acumen to review and contextualize adverse events, protocol deviations, and clinical data; engage with site investigators and coordinators on the clinical significance of findings, escalating appropriately.
• Cultivate trusted, long-term relationships with principal investigators, study coordinators, and site staff; serve as a credible clinical and operational partner who actively fosters site investment and engagement in the study.
• Leverage knowledge of CRM device therapy and cardiovascular disease to engage effectively with site clinical teams, understand the patient population, and interpret device-related clinical data in the context of study objectives.

Other Duties and Responsibilities

• Other duties as assigned.
• Contribute to preparation of clinical study reports including external reports to regulatory agencies, sites, and IRBs.
• Support data management and reporting activities via query generation, query resolution, tabulating, analyzing, and reviewing data in collaboration with data management and biostatistics functions.
• Utilize and tracks monitoring metrics to evaluate monitoring and site performance; facilitate action plans to improve output or mitigate risks of study execution.
• Deliver clear, engaging, and well-structured presentations to research sites (e.g., SIVs, investigator meetings).
• Able to review data tables from clinical database for accuracy that are used for clinical reports or publications.
• Oversee and participate in audit readiness activities, such as maintaining audit ready review of internal process and study document collection and filing.

Supervisory Responsibilities

Not applicable

Qualifications

Education and Required Experience:

• 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. Relevant allied health backgrounds (e.g., RN, cath lab technician, cardiac device clinic coordinator, EP lab technician) are strongly welcomed as qualifying pathways.
• 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.
• Two or more years of experience preferred having responsibility for the conduct of clinical CROs associated with a study (e.g., CRAs, core labs, data management, etc.)
• Class III cardiovascular rhythm management (CRM) device experience (e.g., pacemakers, ICDs, CRT-D) or equivalent implantable cardiovascular device experience is strongly preferred and considered a core expectation of this role.

Knowledge, Skills, and Abilities:

• 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.
• Ability to assess study operations and identify issues and risks that need action or elevation to senior staff.
• Willing and able to travel up to 30%, which may include weekend and overnight trips when appropriate.
• Proven capacity to rapidly tackle complex tasks; demonstrates curiosity, clinical learning agility, and the drive to develop deep domain expertise in cardiovascular device therapy.
• Operates with a high degree of independence and initiative; able to manage complex priorities with minimal supervision.
• Strong program management skills with the ability to organize, plan, and drive multiple site activities forward.
• Builds trust and credibility quickly with physicians, coordinators, and stakeholders.
• Highly motivated self-starter who thrives in dynamic environments with significant travel.
• Collaborative team player who communicates effectively across functions and fosters strong working relationships.
• Strong verbal communication and public speaking skills.
• Working knowledge of Class III CRM device therapy (pacemakers, ICDs, CRT-D) or equivalent cardiovascular implantable device technology; ability to engage with clinical site staff on device-related patient management and data interpretation.
• Skilled at building and sustaining site engagement; able to cultivate genuine investigator and coordinator partnership, inspire site commitment to study goals, and resolve friction proactively.
• Clinical literacy sufficient to review and contextualize adverse events, protocol deviations, and patient data; existing clinical knowledge (e.g., nursing, allied health, or prior device experience) or demonstrated aptitude and eagerness to develop this expertise rapidly.

Physical Requirements:

• Willingness to travel approximately 30% of the time, including visits to the EBR main office (up to one week per month) and attendance at industry events. Travel may include weekends and overnight stay.
• Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend,