Key Responsibilities and Required Skills for Cardiac Clinical Research Associate

🎯 Role Definition

We are seeking a Cardiac Clinical Research Associate (CRA) to manage and monitor cardiology-focused clinical trials across investigator sites. This role ensures protocol adherence, patient safety, high-quality source data verification (SDV), timely adverse event (AE/SAE) reporting, and regulatory compliance (ICH-GCP, FDA, EMA). The ideal candidate combines clinical knowledge of cardiac assessments (ECG, echocardiography, cardiac biomarkers), site relationship management, and strong operational execution to drive trial timelines and data integrity.

Primary keywords: Cardiac Clinical Research Associate, CRA, cardiology trials, site monitoring, ICH-GCP, source document verification, ECG, SAE reporting, EDC, trial master file (TMF).

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) with cardiology trial experience
Research Nurse or Cardiac Nurse with clinical research exposure
Regulatory or Clinical Project Assistant transitioning into monitoring

Advancement To:

Senior Clinical Research Associate (Senior CRA)
Lead CRA / Field Team Lead
Clinical Trial Manager / Project Manager
Clinical Operations Manager / Director, Cardiac Programs

Lateral Moves:

Regulatory Affairs Specialist (clinical submissions)
Clinical Data Manager / Biostatistics Liaison
Clinical Quality Assurance Auditor
Medical Science Liaison (therapeutic specialist)

Core Responsibilities

Primary Functions

Conduct on-site and remote monitoring visits for cardiology studies (site initiation, routine monitoring, close-out) to ensure patient safety, protocol compliance, and data integrity; prepare detailed monitoring visit reports and corrective action plans.
Perform thorough source document verification (SDV) against case report forms (CRFs) and EDC entries for cardiac endpoints including ECGs, echo reports, biomarker labs, device logs, and procedural notes to validate primary and secondary outcome data.
Review, interpret where appropriate, and escalate cardiac safety data (ECG abnormalities, troponin elevations, arrhythmia reporting) in collaboration with medical monitors and safety teams; ensure timely SAE/SUSAR reporting to sponsor and regulatory authorities per protocol and ICH-GCP timelines.
Oversee informed consent processes at investigational sites to confirm proper consent documentation, re-consenting requirements, and that consent conversations appropriately cover device or invasive procedure risks common in cardiology trials.
Manage site regulatory binders/TMF items: verify IRB/EC approvals, protocol versions, CVs, delegations of authority, medical licenses, investigational product (IP) accountability, and device certification records are current and audit-ready.
Execute site qualification and selection activities including feasibility assessments focused on cardiac patient populations, device/equipment availability (ECG machines, echo labs), investigator experience with cardiology endpoints, and anticipated enrollment capacity.
Train site staff on study-specific cardiac procedures (12‑lead ECG acquisition, Holter monitoring, echocardiography timing and documentation, blood draw handling for cardiac biomarkers), and ensure adherence to standardized assessment schedules and imaging protocols.
Monitor investigational product (drug/device) storage, handling, dispensing records and reconciliation at sites; verify device implant logs, reprocessing or maintenance records, and adherence to device-specific regulatory requirements and IDE/510(k) pathways when applicable.
Execute risk-based monitoring (RBM) strategies and centralized monitoring triggers for cardiac safety signals, enrollment outliers, and data discrepancies; escalate trends and recommend remediation to Clinical Operations and Safety teams.
Collaborate with Clinical Project Managers, Data Managers, Biostatisticians and Medical Affairs to resolve open queries, reconcile discrepant cardiac endpoint data, and support database lock activities with focused attention to primary cardiac outcomes.
Maintain timely and precise monitoring documentation in sponsor systems (EDC, Clinical Trial Management System (CTMS), eTMF), ensuring follow-up items are tracked, assigned, and closed per SLA with ownership for site performance metrics.
Support protocol amendments implementation at sites: coordinate training on changes affecting cardiac assessments, update site procedures, and verify re-consenting and regulatory submissions are completed and documented.
Investigate and follow up on protocol deviations, major violations and complaints related to cardiac procedures or device use; drive corrective and preventive actions (CAPAs) with site leadership to restore compliance and protect subject safety.
Facilitate site staff onboarding and competency assessments for cardiac-specific procedures; prepare and deliver remote or on-site refresher trainings to address drift in ECG acquisition, echo timing, or endpoint adjudication workflows.
Participate in investigator meetings, site initiation visits (SIV), and close-out visits to communicate study progress, highlight cardiac safety trends, and ensure complete archiving of study documentation in accordance with regulatory retention policies.
Support patient recruitment and retention strategies by working with site teams to identify barriers in cardiology populations (screening logs, inclusion/exclusion clarifications) and by recommending feasible solutions aligned with protocol integrity.
Coordinate and oversee collection, labeling, storage and shipment of cardiac biospecimens and ECG tracings to central labs or core labs; ensure chain-of-custody documentation and compliance with biospecimen handling SOPs.
Review and confirm accuracy of investigator-initiated event narratives and case documentation for cardiac events and serious adverse events, ensuring clinical content is sufficient for medical review and regulatory reporting.
Prepare targeted site performance summaries and escalation reports for underperforming cardiac sites; propose remedial strategies including supplemental training, additional monitoring frequency, or temporary enrollment holds if patient safety is at risk.
Support vendor oversight and coordination for core labs, device service providers, and imaging adjudication committees; ensure timely data flow, quality of cardiac images/ECGs, and resolution of vendor-generated queries.
Participate in internal cross-functional meetings (safety, data management, clinical operations) to represent site-level insights on cardiac endpoints, protocol feasibility, and operational risks that could impact study timelines.
Maintain continual professional development and therapeutic area expertise in cardiology, attending trainings on ECG interpretation basics, heart failure endpoints, interventional device procedures, and emerging regulatory expectations for cardiovascular trials.

Secondary Functions

Assist with the preparation of monitoring plans, source documents and site training materials focused on cardiac-specific assessments and device handling for study start-up packages.
Support root cause analysis for recurring data queries related to cardiac endpoints and help create site-specific remediation kits, checklists and quick reference guides to improve data quality.
Contribute monitoring metrics and site status updates to CTMS and support generation of operational reports used by study leadership and clinical operations.
Provide backup support for regulatory submissions preparation at the site level, including compilation of site regulatory files for audits and regulatory inspections.
Participate in internal quality assurance initiatives and mock inspections to strengthen site readiness for sponsor audits and regulatory inspections with emphasis on cardiac safety documentation.
Mentor junior CRAs and site coordinators on best practices for cardiac study monitoring and protocol-specific nuances that impact data integrity and patient safety.

Required Skills & Competencies

Hard Skills (Technical)

Profound working knowledge of ICH-GCP, FDA and EMA clinical trial regulations and cardiac device guidance documents.
Site monitoring expertise: initiation, interim, close-out visits, and remote monitoring best practices specific to cardiology studies.
Source Document Verification (SDV) skills with emphasis on ECG logs, echocardiogram reports, procedural notes, and biomarker lab results.
Electronic Data Capture (EDC) systems experience (e.g., Medidata Rave, Oracle Clinical, Veeva), with CRF completion and query resolution proficiency.
Clinical Trial Management System (CTMS) and eTMF usage for monitoring documentation, site tracking and regulatory file management.
Adverse Event (AE/SAE/SUSAR) identification, escalation and regulatory reporting workflow knowledge in cardiac safety contexts.
Experience with central labs, core labs, imaging vendors, and ECG adjudication processes; specimen handling and chain-of-custody protocols.
Risk-Based Monitoring (RBM) and centralized monitoring tool experience to identify cardiac safety or data quality signals.
Investigational Device/Drug accountability and device-specific regulatory compliance (IDE, device logs, maintenance records) for device-inclusive cardiology trials.
Basic interpretation/understanding of 12-lead ECGs, echocardiography reports and cardiac biomarkers to assess data plausibility and flag safety trends.
Proficiency in MS Office (Excel, Word, PowerPoint) and sponsor-specific portals for reporting, dashboards, and slide presentations.

Soft Skills

Excellent verbal and written communication skills for clear site interactions, report writing and cross-functional collaboration.
High attention to detail and meticulous documentation habits to ensure audit-ready monitoring records and TMF completeness.
Strong organizational and time-management capabilities to manage multiple sites, competing priorities and tight regulatory timelines.
Problem-solving and critical thinking to identify root causes of data discrepancies and implement practical corrective actions.
Stakeholder management: ability to build trusted relationships with investigators, site coordinators, and sponsor teams.
Adaptability and resilience to work in varied site environments, including academic centers, community hospitals, and device labs.
Coaching and mentoring ability to upskill site staff and junior CRAs on cardiac-specific study requirements.
Cultural sensitivity and professionalism when working with diverse patient populations and international sites.
Initiative and ownership with a focus on continuous process improvement and operational excellence.
Integrity and ethical decision-making to uphold patient safety and regulatory compliance.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Nursing, Life Sciences, Biomedical Sciences, Pharmacy or related field. Equivalent clinical experience (e.g., RN) may be accepted.

Preferred Education:

Bachelor of Science in Nursing (BSN) or Master’s degree in Clinical Research, Public Health, Nursing, or related life sciences field.
Certifications such as ACRP/SoCRA Certified CRA or GCP certification are advantageous.

Relevant Fields of Study:

Nursing (RN/BSN)
Biomedical Science / Physiology
Pharmacology / Pharmacy
Clinical Research / Public Health
Cardiology or Cardiovascular Science

Experience Requirements

Typical Experience Range: 2–5 years of clinical research experience with at least 1–2 years of monitoring experience; or 3+ years as a site coordinator or research nurse with cardiology exposure.

Preferred:

3–5 years as a CRA with demonstrated experience monitoring cardiology clinical trials (drug and/or device).
Prior exposure to cardiac devices (pacemakers, ICDs, stents), heart failure trials, arrhythmia studies, or investigational cardiac therapies.
Proven track record of successful site management, regulatory compliance, and timely database lock support.