Key Responsibilities and Required Skills for Cardiac Clinical Research Director

🎯 Role Definition

The Cardiac Clinical Research Director leads and scales cardiology clinical research programs across investigator sites, sponsors and industry partners. This role owns end‑to‑end study strategy and operational delivery — including protocol development, site selection, patient recruitment, regulatory submissions, safety oversight, vendor management and budgetary control — while ensuring the highest standards for Good Clinical Practice (GCP), patient safety and scientific integrity. The ideal candidate is an experienced clinical research leader with a track record running multicenter cardiology trials (drug, device, registry, or outcomes), strong stakeholder management skills, and a demonstrated ability to translate clinical priorities into executable trial plans that meet enrollment, quality and regulatory milestones.

📈 Career Progression

Typical Career Path

Entry Point From:

Senior Clinical Research Associate (CRA) with cardiology trial experience
Cardiac Clinical Trials Manager or Site Research Manager
Advanced Practice Registered Nurse (APRN) / Cardiology Nurse with research leadership experience

Advancement To:

Vice President / Head of Clinical Research — Cardiology
Chief Clinical Research Officer (hospital, health system, or biotech)
Medical Director for Cardiology Clinical Programs

Lateral Moves:

Director of Clinical Operations (therapeutic area expansion)
Program Director — Cardiovascular Outcomes & Registries

Core Responsibilities

Primary Functions

Lead the design, development and execution of cardiology clinical research protocols, ensuring clinical relevance, statistical rigor and feasibility across multicenter site networks.
Serve as the primary operational lead for all active cardiac trials, driving enrollment strategy, timelines, milestones, risk mitigation and overall study delivery to meet sponsor and institutional objectives.
Oversee regulatory strategy and submissions for cardiac studies, including IND/IDE support, IRB/EC submissions, FDA interactions, and compliance with ICH-GCP and local regulatory requirements.
Manage cross-functional trial teams (clinical operations, biostatistics, medical monitoring, safety/pharmacovigilance, data management, regulatory affairs and legal) to ensure coordinated study execution and on-time deliverables.
Develop and manage study budgets, forecasts and financial reporting for clinical programs, including contract negotiation with sponsors, vendors and investigative sites to optimize cost-efficiency.
Lead selection, qualification and oversight of investigative sites, CROs and specialty vendors (imaging core labs, device core labs, central labs), holding partners to defined KPIs and quality standards.
Establish and maintain a robust safety surveillance program for cardiac trials, including SAE/AE reporting, adjudication processes, DSMB interactions and escalation procedures to protect patient safety and ensure regulatory compliance.
Define and implement patient recruitment and retention strategies for complex cardiology populations (ACS, heart failure, arrhythmia, structural heart disease), leveraging site engagement, community outreach and real‑world data where appropriate.
Provide medical oversight and scientific input into endpoint definitions, adjudication charters, and statistical analysis plans to ensure clinical endpoints are meaningful and measurable.
Own study start‑up activities (site activation, training, regulatory document collection, eTMF completeness) and continuously improve start‑up timelines through process optimization and capacity planning.
Ensure data quality and integrity by partnering closely with data management and biostatistics teams on EDC configuration, query resolution, source data verification strategies and interim analyses.
Lead protocol amendments and change control processes, assessing operational impact, communicating changes to stakeholders and updating regulatory filings in a timely manner.
Represent the program as the primary contact with sponsor representatives, clinical investigators and institutional leadership, presenting study status, risks and remediation plans at steering committee meetings.
Drive quality assurance and GCP/compliance activities including internal audits, site audit readiness, corrective and preventive actions (CAPA), and continuous process improvement.
Mentor, recruit and develop high-performing clinical research staff and site teams, creating career development plans and ensuring succession readiness for key roles.
Oversee publication strategy and medical communications related to cardiac studies, coordinating abstracts, manuscripts and presentations to maximize scientific impact and sponsor visibility.
Lead technology and process adoption for trial efficiency (CTMS, eTMF, eConsent, remote monitoring and decentralized trial tools) and champion data-driven decision making.
Coordinate investigator training and certification programs, ensuring consistent delivery of protocol requirements, safety reporting and informed consent processes across sites.
Manage contractual relationships and legal agreements (clinical trial agreements, confidentiality agreements, vendor contracts) in collaboration with legal and finance stakeholders.
Develop and report operational KPIs (enrollment trends, query rates, monitoring metrics, budget burn) and translate insights into actionable remediation plans to keep trials on track.
Champion patient-centric initiatives including patient advisory boards, simplified consent, retention support programs and culturally sensitive recruitment practices.
Provide leadership for grant writing, investigator‑initiated study development and collaboration with academic partners to expand the cardiac research portfolio.
Evaluate and integrate real-world evidence and registry data to support study design, feasibility assessments and post-market surveillance for cardiac therapies and devices.
Ensure coordination with hospital clinical services (cardiac catheterization lab, electrophysiology, heart failure clinic) to align research workflows with clinical care and minimize operational disruption.

Secondary Functions

Support institutional strategy by identifying new therapeutic and technology opportunities in cardiovascular research and recommending portfolio prioritization.
Serve on cross‑institution committees (IRB, clinical research governance, safety committees) to shape research policy and elevate program compliance.
Foster external partnerships with industry sponsors, patient advocacy groups and academic collaborators to grow funding and translational research opportunities.
Lead training workshops and knowledge‑sharing sessions on cardiology trial best practices, regulatory changes and emerging technologies for broader clinical research teams.
Develop and maintain knowledge resources (SOPs, toolkit templates, feasibility checklists) to accelerate study start-up and improve consistency across trials.
Participate in community outreach and public communications to raise awareness of cardiac research opportunities and drive diverse patient participation.
Support institutional quality improvement projects that streamline clinical trial operations, reduce patient burden and improve time‑to‑first‑patient-in.
Advise departmental leadership on resource planning, capital investments and strategic hires to scale cardiac research capabilities.

Required Skills & Competencies

Hard Skills (Technical)

Deep knowledge of cardiology clinical trial design, endpoints (e.g., MACE, hemodynamic measures, echocardiographic endpoints), and procedural/device trial considerations.
Regulatory expertise with IND/IDE submissions, FDA/EMA interactions, IRB/EC submissions, and post‑market surveillance requirements.
Strong command of Good Clinical Practice (GCP), ICH guidelines and clinical trial compliance practices.
Proficiency with clinical trial systems: CTMS (e.g., Veeva, Medrio), EDC platforms (Medidata Rave, Oracle Clinical), eTMF and remote monitoring tools.
Experience managing DSMBs, adjudication committees and clinical endpoint committees; familiarity with safety signal detection and reporting.
Budgeting and financial management skills for study budgeting, forecasting and sponsor negotiations.
Ability to interpret biostatistical reports and collaborate on statistical analysis plans and interim analyses.
Experience overseeing imaging core labs, central laboratories and device performance testing in multicenter cardiology studies.
Clinical credentialing/knowledge sufficient to interpret cardiac diagnostic results, PCI/TAVR/ablation procedural notes and clinical case context.
Proven experience running multicenter industry‑sponsored and investigator‑initiated cardiology trials from start‑up through closeout.
Familiarity with decentralized trial components (remote visits, wearable devices, eConsent) and data integration from digital health sources.
Experience with grant writing, investigator‑initiated funding mechanisms and publication planning.

Soft Skills

Executive leadership with demonstrated ability to build and motivate cross‑functional teams and influence senior stakeholders.
Excellent written and verbal communication skills for protocol development, regulatory writing and scientific presentations.
High emotional intelligence and stakeholder management skills to work effectively with PIs, hospital leadership, sponsors and patient communities.
Strategic thinker with strong problem‑solving skills and the ability to prioritize competing operational demands under tight timelines.
Attention to detail with a commitment to data quality, ethical research conduct and continuous improvement.
Strong negotiation skills for managing contracts, budgets and vendor performance.
Mentoring and talent development skills to coach clinical research staff and investigators.
Adaptability to evolving regulatory landscapes, technology changes and trial design innovations.
Collaborative mindset and consensus-building ability across clinical, regulatory, legal and finance partners.

Education & Experience

Educational Background

Minimum Education:

Bachelor’s degree in Nursing, Life Sciences, Biomedical Engineering, Public Health, or related field; OR equivalent clinical experience (e.g., RN, PA, MD) with demonstrable research leadership.

Preferred Education:

Master's degree (MS, MPH) or Doctoral degree (PhD, MD) in Clinical Research, Cardiology, Epidemiology or related field.
Formal certifications such as CCRP, CCRA, or PMP are advantageous.

Relevant Fields of Study:

Nursing (Cardiology specialty)
Medicine (Cardiology)
Clinical Research / Clinical Trial Management
Public Health / Epidemiology
Biomedical Sciences / Bioengineering

Experience Requirements

Typical Experience Range: 8–15 years of progressive clinical research experience, including at least 5 years in leadership roles within cardiology clinical trials.

Preferred:

10+ years of hands‑on experience managing multicenter cardiovascular drug or device trials.
Proven track record of successful study delivery including enrollment achievement, regulatory approvals, and peer‑reviewed publications.
Experience leading teams that interacted with industry sponsors, CROs and academic investigators, and managing complex budgets > $1M.
Prior experience in academic medical centers, tertiary care hospitals, or biotech/medical device companies preferred.