Key Responsibilities and Required Skills for Cardiac Clinical Research Physician

🎯 Role Definition

The Cardiac Clinical Research Physician (also referred to as Principal Investigator or Cardiology Investigator) leads investigator-initiated and industry-sponsored cardiovascular clinical trials. This role combines board-level clinical cardiology expertise with operational oversight of research protocols, regulatory compliance, safety surveillance, subject recruitment and retention, and scientific dissemination. The physician is accountable for study design contribution, site performance, high-quality source documentation, and ensuring patient safety and data integrity throughout the lifecycle of cardiac drug, biologic, and device studies.

📈 Career Progression

Typical Career Path

Entry Point From:

Cardiology attending physician with prior clinical trial participation
Cardiology fellowship graduates with research rotations or academic fellowships
Physician-scientist with a research fellowship (e.g., MPH/PhD + clinical training)

Advancement To:

Director of Cardiovascular Clinical Research
Chief of Clinical Trials / Clinical Research Office Lead
Associate Professor / Professor (if academic track)
Global Principal Investigator or Therapeutic Area Lead in industry

Lateral Moves:

Clinical Trial Medical Director
Clinical Operations Medical Lead
Regulatory Medical Affairs (Cardiology-focused)
Clinical Development Strategy Consultant

Core Responsibilities

Primary Functions

Lead and serve as the Principal Investigator for cardiovascular clinical trials, taking full clinical responsibility for subject safety, study conduct, and adherence to protocol-specific procedures throughout the study lifecycle.
Draft, review, and refine clinical trial protocols, informed consent documents, investigator brochures, and protocol amendments with clear, pragmatic clinical input aligned to regulatory and ethical standards.
Oversee study start-up activities including feasibility assessments, site selection, investigator meetings, training of site staff, contract and budget negotiation support, and ensuring site readiness for enrollment.
Recruit, screen, consent, and enroll eligible cardiac patients while ensuring compliance with inclusion/exclusion criteria, Good Clinical Practice (GCP), and human subject protection regulations.
Conduct and document medical evaluations, cardiovascular assessments, and study-specific procedures (e.g., ECG, echocardiography, invasive hemodynamics) per protocol and maintain detailed source documentation.
Coordinate and supervise safety monitoring and pharmacovigilance activities: timely identification, assessment, and reporting of adverse events (AEs) and serious adverse events (SAEs) to sponsors, IRBs/ECs, and regulatory bodies as required.
Act as sponsor-facing medical contact for triage of clinical questions, medical monitoring, and escalation of safety signals, and participate in safety review boards and Data Safety Monitoring Boards (DSMB) as needed.
Ensure regulatory compliance by preparing and submitting IRB/IEC dossiers, FDA/EMA/other regulatory agency communications, and maintaining regulatory binder documentation and trial master file integrity.
Collaborate closely with study coordinators, research nurses, clinical monitors, and CROs during monitoring visits to resolve queries, ensure source-to-CRF consistency, and implement monitoring-recommended corrective actions.
Oversee randomization, blinding, and treatment allocation processes to maintain trial integrity, including auditing adherence to investigational product handling, storage, dispensing, and accountability.
Provide clinical interpretation of trial data in collaboration with biostatisticians and data managers, author or contribute to clinical study reports, manuscripts, abstracts, and regulatory submissions.
Design and implement strategies to meet enrollment targets, improve retention, and reduce screen failures by optimizing site workflows, pre-screening methodologies, and community engagement.
Lead investigator-initiated research, pilot studies, and translational projects that align with departmental strategic priorities and external grant funding opportunities.
Manage complex interactions with device manufacturers and pharmaceutical sponsors for device implantation, programming, and device-specific endpoints, ensuring procedural competence and documentation.
Apply clinical expertise to endpoint adjudication committees and act as a clinical reviewer for blinded endpoint assessments and independent core lab interactions (e.g., imaging, ECG).
Mentor, supervise, and train residents, fellows, research coordinators, and junior investigators on clinical trial conduct, GCP, and regulatory best practices.
Participate in site-level quality assurance and quality control activities, internal audits, and corrective action plans to continuously improve compliance and data quality.
Implement and oversee study-specific imaging, biomarker, and sample collection procedures (blood, tissue, genetic material), ensuring chain-of-custody and biorepository standards.
Collaborate with multidisciplinary teams (heart failure, interventional cardiology, electrophysiology, cardiac imaging, vascular medicine) to operationalize protocol procedures and co-manage complex patients.
Maintain active medical license(s), board certification in cardiology, and documentation of human research protections training (e.g., GCP, CITI).
Represent the site or institution at scientific conferences, investigator meetings, and sponsor oversight committees; present study results and contribute to scientific dissemination.
Manage budgets and resource allocation for clinical trials at the site level, assist in contracting and budgeting negotiation, and work with finance/business development teams to ensure fiscal responsibility.
Lead continuous improvement in processes that enhance subject safety, protocol compliance, and trial efficiency, including EHR integrations and use of digital health technologies when applicable.
Support regulatory submissions and responses (e.g., IND/IDE amendments, safety reports) with timely, clear medical narratives and source documentation as part of the regulatory dossier.

Secondary Functions

Support development and integration of electronic health record (EHR) tools, pre-screening algorithms, and registries to accelerate candidate identification for cardiovascular trials.
Engage in community outreach, physician network education, and referral relationships to broaden the study recruitment funnel and raise awareness of available cardiac trials.
Serve as a clinical subject matter expert to institutional review boards, research committees, and hospital leadership on cardiovascular research priorities and risk mitigation.
Contribute to departmental strategic planning for research growth, philanthropic efforts, and grant applications to expand trial portfolios.
Participate in interdisciplinary clinical case conferences to align patient care with study protocols and to troubleshoot complex clinical or protocol-related issues.

Required Skills & Competencies

Hard Skills (Technical)

Clinical trial protocol development and implementation specific to cardiology (drug, biologic, and device trials).
Deep knowledge of Good Clinical Practice (GCP), ICH guidelines, FDA/EMA regulations, and local IRB/IEC processes.
Proven experience with electronic data capture (EDC) systems, Clinical Trial Management Systems (CTMS), and electronic medical records (Epic, Cerner or equivalent).
Proficiency in cardiovascular diagnostic modalities (ECG interpretation, transthoracic/transesophageal echocardiography, cardiac MRI/CT basics) relevant to study endpoints.
Medical safety reporting and pharmacovigilance: timely SAE narratives, causality assessment, and regulatory reporting.
Experience serving as Principal Investigator and interacting with sponsors, CROs, and DSMBs.
Familiarity with randomization systems, blinding procedures, investigational product accountability, and device implantation logistics.
Ability to interpret clinical biostatistics outputs, collaborate with statisticians, and translate data results into clinical conclusions.
Competence in writing scientific documents: clinical study reports, manuscripts, investigator brochures, and regulatory submissions.
Experience with clinical endpoints, adjudication processes, core labs, and event classification in cardiovascular trials.
Budget development and contract negotiation experience for clinical trial sites.
Understanding of laboratory and biomarker sample handling, biobanking, and chain-of-custody protocols.

Soft Skills

Strong clinical leadership and decisiveness balanced with collaborative team management.
Excellent verbal and written communication tailored to clinicians, patients, regulatory agencies, and sponsors.
Meticulous attention to detail and high standards for documentation and data quality.
Empathetic patient-centered approach to recruitment, informed consent, and retention.
Effective mentorship and teaching skills for trainees, coordinators, and junior investigators.
Problem-solving orientation with the ability to triage competing priorities in a fast-paced research environment.
Integrity and ethical judgment in human subject protection and conflict-of-interest situations.
Project management and organizational skills to manage multiple studies and timelines simultaneously.
Adaptability to evolving protocol requirements, regulatory changes, and fast-moving safety signals.
Stakeholder management and negotiation skills for cross-departmental alignment and sponsor partnerships.

Education & Experience

Educational Background

Minimum Education:

MD or DO degree with successful completion of a Cardiology fellowship and current board certification or eligibility.
Active, unrestricted medical license in the jurisdiction(s) of practice.
Documented training in human subjects protection and Good Clinical Practice (GCP).

Preferred Education:

Advanced research training (MPH, MS in Clinical Research, or PhD) or formal clinical research fellowships.
Additional certifications in regulatory affairs, clinical trial management, or quality systems are a plus.

Relevant Fields of Study:

Cardiology / Internal Medicine
Clinical Research / Clinical Epidemiology
Cardiovascular Medicine / Heart Failure / Electrophysiology
Public Health / Biostatistics / Translational Science

Experience Requirements

Typical Experience Range: 3–10+ years of clinical practice post-fellowship with at least 2–5 years involvement in cardiovascular clinical research; demonstrated progression from site investigator to lead investigator roles is highly desirable.

Preferred:

Minimum 3–5 years as an investigator on industry-sponsored or NIH-funded cardiovascular trials; prior experience as a site PI strongly preferred.
Track record of enrollment and retention performance, quality source documentation, and successful completion of monitoring visits and audits.
Experience with device trials (IDE) and drug/pharmacologic trials, including interactions with regulatory agencies (IND/IDE submissions) and DSMBs.
Demonstrated authorship on peer-reviewed manuscripts, abstracts, or clinical study reports; experience presenting data at national/international cardiology meetings.
Leadership experience mentoring trainees and leading interdisciplinary research teams.