Key Responsibilities and Required Skills for Cardiac Clinical Research Coordinator

🎯 Role Definition

We are seeking a Cardiac Clinical Research Coordinator (CRC) to manage day-to-day operations of cardiology clinical trials across Phase II–IV drug and device studies. The CRC will be the primary site contact for study participants, the clinical care team, sponsors, and CRO monitors, responsible for ensuring protocol adherence, participant safety, high-quality source documentation, timely data entry, and regulatory compliance. This role requires strong cardiac-specific clinical knowledge (ECG, echocardiography, cardiac biomarkers), excellent communication skills, and experience with electronic data capture (EDC) systems and IRB processes.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Assistant / Research Coordinator I
Registered Nurse (RN) in Cardiology or Cardiac Care Unit
Cardiovascular Technologist or Clinical Trial Assistant

Advancement To:

Senior Clinical Research Coordinator / Lead CRC
Clinical Research Manager / Trial Manager
Study Start-Up Specialist or Clinical Operations Lead
Clinical Project Manager or Research Program Director

Lateral Moves:

Regulatory Affairs Specialist
Clinical Data Manager
Clinical Research Quality Assurance / Audit Specialist

Core Responsibilities

Primary Functions

Screen and identify eligible patients for cardiology clinical trials by reviewing EMR data, specialty clinic lists, diagnostic test results (ECG, echocardiogram, stress tests), and communicating directly with treating cardiologists to confirm eligibility and optimize enrollment.
Conduct informed consent discussions with prospective participants and legally authorized representatives, ensuring comprehension of trial procedures, risks, benefits, and rights, and document consent according to IRB and institutional policies.
Coordinate and schedule study visits, baseline and follow-up cardiac assessments (12‑lead ECGs, Holter monitors, echocardiography, cardiopulmonary exercise testing), and laboratory draws to align with protocol windows and minimize patient burden.
Perform protocol-required cardiac assessments and standardized procedures including acquisition of high-quality 12‑lead ECGs, orthogonal lead placement, resting vs. exercise ECGs, and accurate labeling and transfer of ECGs to sponsor/CRO per study specifications.
Collect, process, ship, and document biological specimens (serum, plasma, whole blood, urine) for cardiac biomarkers (troponin, BNP/NT‑proBNP) according to protocol, chain-of-custody, and laboratory partner requirements, ensuring proper temperature control and documentation.
Maintain complete, accurate, and contemporaneous source documentation in participant charts and source documents, reconcile source data to eCRFs/EDC, resolve data queries promptly, and facilitate timely data lock activities.
Enter case report form (CRF) data into EDC systems (e.g., Medidata Rave, REDCap, Oracle Clinical, Viedoc) with attention to consistency, audit trail integrity, and query resolution, collaborating with data management as needed.
Monitor and report adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol, sponsor, FDA, and IRB reporting timelines; prepare SAE narratives, facilitate medical review and unblinding when required, and track outcomes.
Prepare and maintain regulatory documents including the regulatory binder/ISF (investigator site file), protocol versions, informed consent forms, delegation logs, CVs, medical licenses, training records, and laboratory manuals to ensure inspection readiness.
Coordinate site initiation, monitoring visits, and closeouts with sponsors and CROs; manage monitor access to source documentation, provide requested source files, and implement corrective and preventive action (CAPA) plans as applicable.
Implement and maintain participant safety monitoring procedures specific to cardiology trials (arrhythmia surveillance, device interrogation, hemodynamic monitoring) and escalate safety concerns to investigators and sponsors immediately.
Support cardiac device-specific activities such as device inventory management, device implant visit coordination, device troubleshooting, and retrieval of device telemetry or interrogation reports for submission.
Serve as primary liaison between investigators, cardiology clinic staff, nursing teams, cardiac imaging labs, laboratory partners, and pharmacy to coordinate study logistics and ensure protocol-aligned participant care.
Train and supervise site research staff, delegated clinical personnel, and students on protocol procedures, GCP principles, study SOPs, and cardiac-specific procedures to ensure consistent, high-quality data collection.
Conduct pre-screening and retention outreach, including phone calls, reminder communications, transportation coordination, and barrier assessment to maximize participant adherence to visit schedules and study completion.
Prepare study budgets, track subject stipends and reimbursements, and collaborate with clinical research billing and finance teams to ensure compliant billing practices and accurate study invoicing.
Participate in feasibility assessments, site selection activities, and study start-up meetings by providing input on enrollment potential, available patient populations, and site resources specific to cardiology research.
Assist investigators with protocol amendments, IRB submissions, continuing review reports, and post-approval modifications, ensuring timely documentation and implementation at the site level.
Conduct quality control checks, self-audits, and root cause analyses to identify documentation gaps or protocol deviations and lead remediation activities to uphold data integrity and regulatory compliance.
Manage investigational product (IP) handling when applicable, including receipt, temperature‑controlled storage, accountability logs, dispensing, reconciliation, and destruction per sponsor instructions and institutional policy.
Facilitate multidisciplinary case reviews and investigator meetings to review safety signals, enrollment performance, protocol adherence, and opportunities to improve operational efficiency.
Coordinate cardiac imaging transfers, external lab result retrievals, and medical records abstraction required for endpoint adjudication committees and blinded core laboratories.
Maintain up-to-date knowledge of relevant regulations (FDA, ICH-GCP), institutional policies, and cardiology-specific best practices; participate in ongoing education and certification maintenance.

Secondary Functions

Contribute to development of recruitment strategies, patient-facing materials, and community outreach initiatives to broaden trial awareness among heart disease populations (heart failure, atrial fibrillation, ischemic heart disease).
Support budgeting, contracting, and insurance coverage determination activities with sponsors, finance, and legal teams to expedite study start-up and secure site resources.
Collaborate with clinical data managers to support cleaning activities, discrepancy management, and preparation for database lock and interim analyses.
Participate in site-level process improvement projects to streamline clinic-flow for research visits, reduce no-shows, and improve throughput for cardiac testing resources.
Assist with vendor coordination (central labs, ECG core labs, imaging core labs, device vendors) including initiation, sample shipment logistics, and vendor question resolution.
Prepare materials and logistics for internal and external audits and inspections, including rapid retrieval of regulatory documents, training logs, and source records.
Provide back-up clinical coverage for other cardiovascular studies as needed and facilitate cross-training across study teams to maintain operational continuity.
Support investigator-initiated trials and quality-improvement research activities by assisting with protocol writing, statistical plan input, and study documentation.

Required Skills & Competencies

Hard Skills (Technical)

Good Clinical Practice (GCP) knowledge and demonstrated application in cardiology clinical trials.
Strong understanding of FDA regulations and ICH guidelines relevant to human subjects research.
Proficiency with EDC and eCRF systems such as Medidata Rave, REDCap, Oracle Clinical, or Viedoc, including query resolution workflows.
Clinical skills in cardiac testing: acquisition and quality control of 12-lead ECGs, Holter monitor setup, and coordination of echocardiography and stress testing.
Phlebotomy and specimen processing experience with strict adherence to chain-of-custody and cold-chain specimen shipping procedures.
Experience with adverse event and SAE reporting, safety monitoring, and event narratives preparation.
Regulatory documentation management: preparing IRB submissions, continuing reviews, amendments, and maintenance of the investigator site file.
Investigational product management knowledge, including temperature-controlled storage, accountability, and dispensing documentation.
Familiarity with source data verification (SDV) practices and clinical monitor interactions.
Basic familiarity with cardiac device data retrieval (pacemaker/ICD interrogation) or ability to coordinate device vendor support when required.
Proficiency in Microsoft Office suite (Word, Excel — pivot tables, VLOOKUPs for tracking), and comfort with electronic health record (EHR) navigation for chart review and eligibility confirmation.
Budget tracking and clinical trial billing coordination experience, including interactions with research finance and billing compliance teams.

Soft Skills

Exceptional written and verbal communication skills for participant interactions, sponsor correspondence, and multidisciplinary collaboration.
Strong organizational skills with the ability to manage multiple protocols, competing deadlines, and complex scheduling in a fast-paced cardiology environment.
Attention to detail and high level of accuracy in documentation, data entry, and regulatory recordkeeping.
Empathy and patient-centered approach to engaging cardiovascular patients and their caregivers, including handling sensitive health information with compassion.
Problem solving and critical thinking to identify barriers to enrollment, troubleshoot operational issues, and escalate appropriately.
Team-oriented mindset with demonstrated ability to train, mentor, and coordinate clinical and research staff.
Adaptability to changing protocol requirements, regulatory updates, and varied study designs including device and drug trials.
Time management and prioritization skills to balance urgent safety concerns with routine study tasks.
Cultural competence and ability to work effectively with diverse patient populations and multidisciplinary care teams.
Professionalism and integrity in maintaining participant confidentiality and compliance with ethical research standards.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Nursing (BSN), Health Sciences, Biology, Public Health, or related field. Registered Nurses (RN) with cardiac experience are strongly encouraged to apply.

Preferred Education:

Bachelor’s degree with CRC certification (CCRC, CCRP, SOCRA) or Master’s degree in Clinical Research, Nursing, Public Health, or related discipline.

Relevant Fields of Study:

Nursing (Cardiology experience preferred)
Biology / Physiology
Public Health / Health Sciences
Clinical Research / Research Administration

Experience Requirements

Typical Experience Range:

2–5 years of clinical research coordination experience, with at least 1–2 years supporting cardiology or cardiovascular trials preferred.

Preferred:

3+ years of direct experience coordinating cardiology clinical trials (drug and/or device), experience with EDC systems, IRB submissions, SAE reporting, and cardiac procedure coordination (ECG/echo).
Certifications such as CCRC, CCRP, or SOCRA and BLS/ACLS are advantageous. Demonstrated experience working with cardiac imaging core labs, device vendors, or heart failure/arrhythmia study populations is highly desirable.