Key Responsibilities and Required Skills for Cardiac Clinical Research Specialist

🎯 Role Definition

The Cardiac Clinical Research Specialist is a clinical research professional responsible for planning, coordinating, and executing cardiovascular clinical trials and observational studies. This role supports cardiology investigators and multi-disciplinary teams to ensure protocol compliance, accurate data capture, patient safety, and timely regulatory reporting across drug, biologic, and device studies. The Specialist acts as a conduit between sponsors, CROs, institutional review boards (IRBs), and clinical teams while driving enrollment, retention, and high-quality source documentation to meet study milestones.

Key SEO terms: cardiac clinical research specialist, cardiology clinical trials, clinical research coordinator, cardiac device trials, GCP, IRB, EDC, SAE reporting, patient recruitment, protocol adherence.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Coordinator (CRC) — general medicine or cardiology
Registered Nurse (RN) with clinical trial experience
Clinical Research Assistant or Study Assistant

Advancement To:

Senior Clinical Research Specialist / Lead CRC
Clinical Research Manager / Clinical Trials Manager
Clinical Project Manager (cardiology-focused)
Clinical Operations Lead or Site Principal Investigator coordinator

Lateral Moves:

Clinical Research Associate (CRA) — sponsor/CRO monitoring role
Regulatory Affairs Specialist or Clinical Quality Assurance
Data Manager / Clinical Data Coordinator

Core Responsibilities

Primary Functions

Plan, coordinate and execute all clinical trial activities for cardiology studies at the site level, including site initiation, screening, enrollment, study visits, and closeout to ensure milestones are met and study timelines are adhered to.
Manage patient recruitment and retention strategies for cardiac clinical trials, including outreach to cardiology clinics, inpatient units, electrophysiology labs, heart failure programs, and community providers to meet enrollment targets.
Conduct informed consent discussions with prospective participants, ensuring comprehension of study objectives, procedures (e.g., echocardiograms, ECGs, catheterization lab procedures), risks, and rights; obtain and document legally valid informed consent per GCP and IRB requirements.
Oversee source documentation and case report form (CRF) completion; verify accuracy, completeness, and timeliness of data entered in the electronic data capture (EDC) system (e.g., Medidata Rave, REDCap) and resolve data queries in collaboration with data management.
Perform regular quality control and monitoring-readiness checks of source documents, regulatory binders, delegation logs, and study files to ensure inspection readiness and compliance with sponsor/CRO and institutional standards.
Triage, document, and report adverse events (AEs) and serious adverse events (SAEs) in accordance with protocol, sponsor/CRO SOPs, IRB reporting timelines, and applicable regulatory agency requirements (e.g., FDA reporting where applicable).
Coordinate and schedule protocol-required cardiac tests and procedures (ECG, Holter monitoring, echocardiography, cardiac MRI, stress testing, catheterization labs), ensuring test results are available and incorporated into study records.
Serve as the primary liaison between site investigators, cardiology sub-specialists, sponsor monitors/CROs, IRBs, and clinical teams to facilitate communications, site visits, monitoring, and audit activities.
Maintain and update regulatory documents, including IRB submissions and amendments, informed consent forms (ICFs), protocol training logs, CVs, medical licenses, and institutional approvals throughout the study lifecycle.
Develop and maintain patient-facing study materials, visit checklists, and standard operating procedures to ensure consistent delivery of study procedures and high-quality participant experience.
Train and supervise research staff, study nurses, and coordinators on protocol-specific procedures, GCP, source documentation standards, and safety reporting to ensure consistent adherence across the team.
Manage investigational product handling for device and drug studies: inventory, storage conditions, accountability logs, reconciliation, and return or destruction per sponsor instructions and regulatory requirements.
Support remote and hybrid trial activities including telehealth visits, remote monitoring, home health coordination for vitals/ECGs, and electronic patient-reported outcome (ePRO) collection while maintaining data security and privacy (HIPAA).
Prepare for and support sponsor and regulatory monitoring visits, including compilation of monitoring binders, facilitating access to source documentation, and implementing corrective and preventive actions (CAPAs) when needed.
Assist with protocol feasibility assessments and site selection activities by providing historical enrollment data, resource assessments, and cardiac-specific procedural volumes to sponsors and investigators.
Perform eligibility screening and adjudication for protocol inclusion/exclusion criteria, coordinate baseline assessments and randomization procedures, and ensure appropriate stratification steps are followed.
Coordinate and document study-related training for site personnel, including protocol-specific training, adverse event reporting procedures, and safety monitoring plans; maintain training logs and attestations.
Contribute to study startup activities such as budget negotiation, site contracts, institutional reliance agreements, billing grid reconciliation, and study-specific SOP development in collaboration with clinical research administration.
Oversee specimen management logistics for cardiac biomarkers and other lab assays: collection, labeling, processing, shipment to central labs, chain-of-custody documentation, and temperature monitoring for biologic samples.
Collaborate with multidisciplinary clinical teams (interventional cardiology, electrophysiology, heart failure, imaging, nursing) to coordinate complex procedures and ensure protocol-specific timing and safety requirements are met for participants.
Lead continuous improvement initiatives to streamline enrollment workflows, reduce time-to-first-patient-in, enhance data quality, and increase patient satisfaction scores in cardiac research programs.
Maintain confidentiality and patient privacy in all research activities in compliance with HIPAA, institutional policies, and sponsor requirements, and support ethical conduct of research at all times.
Generate routine study status reports, enrollment metrics, safety reports, and regulatory updates for investigators, sponsors, and departmental leadership to support data-driven decision making.

Secondary Functions

Support investigator-initiated studies by assisting with protocol development, budget planning, and grant applications specific to cardiovascular research.
Participate in institutional research committees, clinical trial steering committees, and safety review boards to provide site-level perspective on cardiology studies.
Mentor junior research staff and participate in cross-training programs to build site research capacity and resilience.
Assist with patient engagement programs, community outreach, and educational events to raise awareness of cardiac clinical trial opportunities and improve diversity in enrollment.
Coordinate vendor relationships for external services (ECG core labs, central labs, imaging core labs, device vendors) and ensure service level agreements (SLAs) are met.
Contribute to post-study activities including database lock support, file archiving, and long-term retention of research records per institutional and sponsor policies.
Assist with budget tracking, invoicing, and financial reconciliation for study accounts; escalate financial or billing issues to research administration.
Support quality improvement and compliance audits by participating in mock monitoring visits, root cause analyses, and implementation of CAPAs where applicable.

Required Skills & Competencies

Hard Skills (Technical)

Good Clinical Practice (GCP) certification and practical knowledge of ICH-GCP principles applied to cardiology clinical trials.
Clinical trial coordination and site management experience specific to cardiac drug, biologic, or device studies.
Electronic Data Capture (EDC) proficiency: Medidata Rave, REDCap, Oracle Clinical or similar systems; CRF completion and query resolution.
Regulatory submission and IRB management: protocol/amendment submissions, continuing reviews, and safety reporting workflows.
Adverse event (AE/SAE) identification, grading, documentation and expedited reporting per sponsor and regulatory timelines.
Source documentation best practices, medical record abstraction, and audit-ready file maintenance for cardiovascular procedures (ECG, echo, cath).
Investigator/site monitoring support skills, including sponsor monitoring visit preparation, corrective action tracking, and audit response.
Investigational product (drug/device) accountability and handling, including temperature-sensitive storage and controlled inventory reconciliation.
Cardiology-specific procedural familiarity (ECG interpretation basics, echocardiography results, catheterization lab workflows, device implant processes).
Clinical research billing and study budget coordination, including understanding of billing compliance and clinical trial finance.
Proficiency with Microsoft Office suite (Word, Excel, PowerPoint), scheduling systems, and basic familiarity with data visualization for enrollment metrics.
Experience with remote/hybrid trial tools: telehealth platforms, ePRO systems, and decentralized trial workflows.

(At least 10 technical competencies included)

Soft Skills

Strong verbal and written communication tailored to patients, clinical teams, sponsors, and regulatory bodies.
High attention to detail and accuracy in complex documentation and data entry.
Time management and organizational skills to balance multiple concurrent studies and competing deadlines.
Problem-solving and critical thinking when addressing protocol deviations, enrollment barriers, and monitoring findings.
Empathy and patient-centered approach to recruit, consent, and retain cardiac patients and vulnerable populations.
Collaboration and teamwork across multi-disciplinary clinical and research staff.
Initiative and adaptability in a fast-paced research environment with changing protocols and regulatory landscapes.
Professionalism, discretion, and commitment to research ethics and patient confidentiality.
Leadership potential to mentor junior staff and lead study-specific initiatives.
Cultural competence and ability to interact respectfully with diverse patient populations.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Nursing (BSN), Biological Sciences, Health Sciences, or related field. Equivalent healthcare experience (e.g., RN) accepted for clinical roles.

Preferred Education:

Bachelor’s in Nursing (BSN) or Master's degree in Clinical Research, Public Health, Nursing, or a related discipline.
Professional certification such as CCRC, CCRP, or SOCRA/CITI advanced certifications preferred.

Relevant Fields of Study:

Nursing (BSN)
Biology, Physiology or Biomedical Sciences
Public Health or Clinical Research Management
Health Administration or related health science disciplines

Experience Requirements

Typical Experience Range:

2–5 years of clinical research experience, with at least 1–2 years specifically in cardiology or cardiovascular device/drug trials.

Preferred:

3–5+ years in cardiac clinical trials or cardiovascular device research, experience with sponsor/CRO interactions, monitoring visits, and complex procedural coordination (e.g., electrophysiology, cath lab, heart failure clinics).
Prior experience as a CRC/CRA, RN in cardiology, or research coordinator at an academic medical center or high-volume cardiac site preferred.