Key Responsibilities and Required Skills for Cardiac Clinical Research Nurse

🎯 Role Definition

The Cardiac Clinical Research Nurse is a licensed registered nurse who coordinates and conducts cardiac-focused clinical trials and observational studies. This role manages patient recruitment and consent, performs cardiac assessments and protocol-driven procedures (ECG, echocardiography coordination, vitals and hemodynamic monitoring), ensures regulatory compliance with ICH-GCP and institutional IRBs, maintains accurate source documentation and eCRFs, reports adverse events and collaborates with multidisciplinary teams including principal investigators, study sponsors, monitors, and laboratory services. The nurse acts as a patient advocate, educator, and trusted clinical resource throughout the study lifecycle.

📈 Career Progression

Typical Career Path

Entry Point From:

Registered Nurse (RN) with cardiac/critical care experience (CCU, CICU, step-down)
Clinical Research Coordinator (CRC) or Research Assistant in cardiology trials
Cardiology Nurse (including Heart Failure, Interventional Cardiology, Electrophysiology)

Advancement To:

Senior Clinical Research Nurse / Lead Research Nurse
Clinical Research Manager / Study Manager (Cardiology portfolio)
Clinical Trials Program Director or Clinical Research Operations Lead

Lateral Moves:

Clinical Research Coordinator for other therapeutic areas
Research Nurse Educator / Trainer
Clinical Quality Assurance or Regulatory Affairs specialist

Core Responsibilities

Primary Functions

Lead end-to-end coordination of cardiology clinical trials including subject screening, eligibility verification, recruitment, enrollment, and protocol-driven follow-up visits to ensure study timelines and enrollment targets are met.
Obtain and document informed consent in accordance with ICH-GCP, local regulations and IRB policies, ensuring patients understand study procedures, risks, benefits and their rights as research participants.
Conduct protocol-specific cardiac assessments such as 12-lead ECG acquisition and interpretation support, review and documentation of heart rate and rhythm, coordination of ambulatory ECG/Holter monitoring, and liaise with cardiology specialists for abnormal findings.
Schedule, prepare and coordinate echocardiography, stress testing, cardiac MRI and other imaging studies required by study protocols; ensure results are captured in source documentation and transferred to eCRF/EDC systems.
Perform clinical procedures within scope of practice (vital signs, phlebotomy, IV insertion, medication administration per protocol, device implant support and post-procedure assessments) and ensure appropriate patient monitoring and documentation.
Maintain accurate and timely source documentation and complete case report forms (CRFs/eCRFs) in the assigned electronic data capture (EDC) system (e.g., Medidata Rave, REDCap, Oracle Clinical), resolving queries and discrepancies in collaboration with monitors and data managers.
Manage adverse event (AE) and serious adverse event (SAE) identification, documentation, grading and expedited reporting to sponsor, safety officer and IRB according to protocol, regulatory requirements and institutional policies.
Coordinate and host sponsor and CRO monitoring visits, providing complete regulatory binder, source data, drug/device accountability logs, and responding to monitoring findings with corrective actions and CAPAs.
Maintain investigational product/device accountability including receipt, storage, dispensing, returns, reconciliation, and temperature log documentation in compliance with sponsor and institutional requirements.
Perform screening and baseline assessments including past medical history, concomitant medications, NYHA functional class, lab draws and review of prior cardiac procedures to determine subject eligibility.
Oversee specimen collection, processing, labeling, storage and shipping for biobanking, PK/PD and centralized lab testing according to protocol and chain-of-custody requirements.
Conduct medication reconciliation, document concomitant medication use, and educate participants on study drug/device instructions, side-effect monitoring and safety reporting procedures.
Ensure compliance with HIPAA, local institutional policies and federal regulations (FDA, OHRP) in all research-related documentation and communications.
Collaborate with investigative team to develop, review and implement study-specific procedures, source documents, SOPs and case report templates to optimize data quality and workflow efficiency.
Participate in protocol feasibility assessments, recruitment planning, and outreach strategies to identify and engage eligible cardiac patient populations, including clinic screening and inpatient consults.
Provide participant education, symptom management and triage for cardiac-related events; coordinate emergent clinical care or hospital transfers when required, and notify the PI per protocol.
Support protocol amendments, investigator-initiated study setup, and IRB submissions by preparing clinical content, safety summaries and investigator brochures as needed.
Train and mentor research staff, nursing colleagues and rotating clinical personnel on study procedures, GCP, informed consent process and emergency response protocols specific to cardiac trials.
Prepare study visit calendars, track subject visit windows and adherence, and proactively manage missed visits, re-scheduling and retention strategies to minimize protocol deviations and attrition.
Utilize electronic health records (EHR) and registries to abstract clinical data, complete source verification and ensure concordance between clinical notes and eCRF entries during data cleaning and closeout.
Assist in the preparation of regulatory documents, study close-out activities, final reports and contribute clinical input to publications, abstracts and presentations related to cardiac research.
Implement quality control and process improvement initiatives to enhance patient safety, data integrity and trial efficiency; escalate systemic issues to leadership and implement corrective actions.
Act as a liaison between cardiology clinical services, research pharmacy, laboratory and imaging departments to ensure integrated delivery of protocol-required care.

Secondary Functions

Support grant applications and budget development by providing clinical cost estimates, recruitment feasibility and input on study procedures.
Participate in community outreach and patient education events to raise awareness of cardiac research opportunities and improve recruitment diversity.
Assist with development and maintenance of training materials, SOPs and competency checklists for cardiac research nursing staff.
Help coordinate investigator meetings, interdisciplinary research meetings and internal audits related to cardiology trials.
Contribute to manuscript writing, abstract submission and poster preparation by supplying clinical data summaries and patient outcome context.
Maintain inventory of study supplies, research equipment and emergency medications; initiate procurement requests and manage vendor communications.
Support process mapping and workflow standardization for multi-site studies and act as site representative during multicenter study calls.
Facilitate remote/virtual visits and telehealth assessments for decentralized cardiac trial activities, ensuring data capture and participant safety.
Assist regulatory team with annual IRB continuing reviews, safety reports and study renewals by compiling clinical documentation and safety summaries.
Provide backup coverage for other research nurses, including after-hours on-call assistance for urgent study-related adverse events.

Required Skills & Competencies

Hard Skills (Technical)

ICH-GCP and FDA regulations knowledge — demonstrated experience applying GCP principles in cardiac clinical trials and device studies.
Informed consent process: skilled in obtaining and documenting consent for vulnerable cardiac populations and complex trial designs.
Adverse event/SAE reporting: proficiency in timely identification, grading (CTCAE familiarity where applicable), documentation and regulatory reporting.
EDC/eCRF expertise: hands-on use of Medidata Rave, REDCap, Oracle Clinical, Castor or equivalent for data entry, query resolution and source-data verification.
Cardiac assessment skills: 12-lead ECG acquisition, rhythm recognition support, coordination of echo/MRI/stress testing and familiarity with cardiac biomarkers (BNP, troponin).
Phlebotomy and specimen handling: venipuncture, blood processing, labeling, cold-chain management and shipping (CFR/IATA basics where applicable).
Investigational product/device management: accountability, storage, dispensing procedures and returns for investigational drugs and cardiac devices.
Regulatory document management: IRB submissions, continuing reviews, protocol amendments, delegation logs and regulatory binder maintenance.
Clinical documentation & chart abstraction: accurate source documentation in EHR and alignment with CRF entries to support monitoring and audits.
Basic ACLS/BLS certification and clinical assessment skills for rapid triage of cardiac events during study visits.
Familiarity with hospital workflows and multidisciplinary coordination (pharmacy, imaging, lab, cath lab and electrophysiology suites).
Data privacy & security: HIPAA compliance and secure handling of participant health information in clinical research contexts.

Soft Skills

Strong patient-centered communication and teaching skills; ability to explain complex research procedures to patients and families with empathy.
Critical thinking and clinical judgment to identify safety signals, escalate concerns and support decision-making under protocol constraints.
Attention to detail and high level of organization to manage competing study timelines, complex visit windows and regulatory documentation.
Team collaboration and stakeholder management — works effectively with PIs, coordinators, sponsors, CROs and clinical departments.
Time management and prioritization to balance direct patient care, documentation, scheduling and monitoring requirements.
Problem solving and adaptability in fast-paced clinical trial environments and during unplanned clinical events.
Cultural competence and ability to engage diverse patient populations to support equitable recruitment and retention.
Leadership and mentoring skills for onboarding, training and supervision of junior research staff.
Professionalism and integrity in handling sensitive data, conflict resolution and adherence to ethical research conduct.
Resilience and emotional intelligence for coping with patient acuity, adverse events and the demands of clinical research.

Education & Experience

Educational Background

Minimum Education:

Current, active Registered Nurse (RN) license in state of practice; ADN acceptable with relevant research experience.

Preferred Education:

Bachelor of Science in Nursing (BSN) strongly preferred.
Advanced degrees (MSN, MPH, MS Clinical Research) or clinical research certifications (CCRP, SOCRA, ACRP) are advantageous.

Relevant Fields of Study:

Nursing (Cardiology, Critical Care, Clinical Research)
Clinical Research / Clinical Trials Management
Biomedical Sciences, Health Sciences, or related life-science fields

Experience Requirements

Typical Experience Range:

2–5 years of nursing experience with at least 1–3 years in cardiology, cardiac care unit, or clinical research setting.

Preferred:

3–5+ years total RN experience with 2+ years specifically in cardiac clinical research or cardiology clinical practice.
Prior exposure to device trials (implantable devices, electrophysiology) or heart failure/pharmacologic cardiology studies.
Demonstrated experience with GCP-compliant trial conduct, sponsor/CRO interactions and successful audit/monitor visit management.