Key Responsibilities and Required Skills for Cardiac Clinical Research Fellow

🎯 Role Definition

The Cardiac Clinical Research Fellow leads and supports clinical and translational cardiology research projects within an academic or hospital setting. This role combines direct patient-facing activities (screening, consent, study visits), high-quality data collection and management, regulatory compliance (GCP/ICH/IRB), coordination with sponsors/CROs, and scientific dissemination (abstracts, manuscripts, grant writing). The Fellow will work closely with PIs, multidisciplinary cardiology teams, imaging core labs and biostatistics to deliver investigator-initiated and industry-sponsored studies across heart failure, coronary disease, arrhythmia/device, and structural heart disease portfolios.

📈 Career Progression

Typical Career Path

Entry Point From:

Cardiology registrar or cardiology specialty trainee with protected research time
Medical doctor with prior clinical research experience (MD/MBBS + research year)
PhD or MD-PhD in cardiovascular sciences transitioning to clinical fellowship

Advancement To:

Senior Clinical Research Fellow / Clinical Lecturer (Academic)
Principal Investigator (PI) / Head of Cardiac Research Unit
Consultant Cardiologist with academic appointment
Clinical Research Lead / Clinical Trials Manager

Lateral Moves:

Clinical Research Manager / Study Coordinator Lead
Cardiac Imaging Research Scientist
Industry Clinical Science or Medical Affairs roles

Core Responsibilities

Primary Functions

Lead the day-to-day delivery of investigator-led and sponsored cardiology clinical trials, including participant screening, informed consent, enrollment, scheduling study visits, and ensuring protocol adherence for outpatient and inpatient cardiac populations.
Conduct comprehensive cardiovascular assessments required by study protocols (history, physical exam, 12‑lead ECG interpretation, vital signs, NYHA class) and document findings accurately in source documents and eCRFs/EDC systems.
Perform and oversee advanced cardiac imaging assessments per protocol (echocardiography, Doppler, strain imaging, cardiac MRI, CT angiography) and coordinate image transfer to imaging core labs; ensure standardized acquisition and quality control.
Manage device and interventional cardiology trials logistics (pacemakers, ICDs, LVAD, TAVR, MitraClip, PCI devices), coordinating with cath lab staff, device representatives, and interventionalists for implantation, follow-up, and device troubleshooting.
Prepare, review and implement clinical trial protocols, amendments, informed consent forms and investigator brochures; contribute to study design discussions and feasibility assessments.
Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, local regulations and institutional policies; maintain training records and SOP adherence for all study personnel.
Serve as primary liaison with sponsors, contract research organizations (CROs), site monitors, and clinical trial units for site initiation visits, monitoring visits, query resolution, and study audits.
Complete and submit regulatory documents including IRB/REC submissions and continuing reviews, safety reports, serious adverse event (SAE) notifications, and protocol deviation reports within required timelines.
Oversee data capture and quality control in electronic data capture (EDC) platforms (e.g., REDCap, Oracle Clinical, Medidata Rave), respond to data queries, perform source data verification, and coordinate database lock activities with data managers.
Implement and maintain study-specific SOPs for specimen collection, processing, storage, and shipment for biomarker and translational sub-studies; coordinate with biobank and laboratory partners to ensure chain-of-custody and cold-chain integrity.
Coordinate and lead multidisciplinary research meetings, investigator meetings, and steering committee activities; prepare agendas, minutes, action logs and follow-up tasks.
Supervise, train and mentor junior research staff, clinical research coordinators, and trainees in trial procedures, consent processes, documentation and good clinical practice principles.
Develop and manage study budgets and site-level budgets, support grant applications and funding proposals, track study expenses and support invoicing and contract negotiation with sponsors.
Design and implement patient recruitment and retention strategies for cardiac populations, including liaising with outpatient clinics, inpatient wards, community heart failure services and general practitioners to reach target enrollment.
Conduct long-term patient follow-up for clinical endpoints, adverse events, medication changes, rehospitalizations and mortality; maintain up-to-date contact logs and follow-up trackers.
Perform interim analyses and prepare data summaries, tables and figures in collaboration with biostatisticians; contribute to statistical analysis plans and interpretation of trial results.
Draft, edit and submit abstracts, posters and oral presentations to national and international cardiology conferences (AHA, ESC, ACC); lead manuscript preparation for peer-reviewed journals and coordinate authorship contributions.
Participate in safety oversight activities including preparing materials for Data Safety Monitoring Boards (DSMB) and responding to DSMB recommendations and protocol amendments.
Maintain comprehensive and auditable trial records (TMF, regulatory files, consent forms) to support inspections and compliance; prepare for and support internal and external regulatory inspections.
Identify and escalate operational risks, implement corrective and preventive actions (CAPAs) and drive continuous improvement initiatives to optimize trial conduct and participant safety.
Coordinate ancillary research activities such as exercise testing, invasive hemodynamics, ambulatory monitoring (Holter, event monitors), and quality-of-life assessments, ensuring standardized procedures across sites.
Engage with patient and public involvement (PPI) groups to incorporate patient perspectives in protocol development, consent language and study materials to enhance recruitment and relevance.
Manage confidentiality, data protection and GDPR requirements for personal health information in research datasets and biological samples, working with institutional data governance teams.

Secondary Functions

Support departmental audit and quality improvement projects related to clinical research processes and patient safety.
Contribute to the development of training curricula and run GCP/ICH refresher sessions for clinical staff involved in trials.
Assist in the preparation of institutional research reports, annual progress reports and local performance dashboards for sponsors and funders.
Facilitate collaborations with basic science and translational laboratories to integrate mechanistic studies with clinical trial outcomes.
Participate in teaching sessions for medical students, residents and fellows on research methodology, clinical trial design and cardiac disease management.
Help maintain and update study-specific patient-facing materials (participant information sheets, diaries, recruitment flyers) and online trial presence to support digital recruitment.
Backfill clinical duties in the cardiology service as agreed with the department, ensuring continuity of clinical care while protecting research integrity.
Support grant writing and preparation of research funding applications by contributing preliminary data, literature reviews and methodological sections.

Required Skills & Competencies

Hard Skills (Technical)

Good Clinical Practice (GCP) certification and demonstrable knowledge of ICH-GCP guidelines.
Clinical trial protocol development and amendments experience, including drafting informed consent and CRFs/eCRFs.
Proficiency with electronic data capture (EDC) systems such as REDCap, Medidata Rave, Oracle Clinical or similar.
Experience with cardiovascular imaging protocols (echo, cardiac MRI, CT) and familiarity with image transfer, DICOM standards and imaging core-lab workflows.
Competence in ECG acquisition and interpretation, ambulatory monitoring and basic arrhythmia recognition.
Strong regulatory knowledge: IRB/REC submissions, SAE reporting, regulatory timelines and inspections readiness.
Experience managing device trials and working with device manufacturers and cath lab environments.
Familiarity with sample handling, biobanking, and lab coordination for biomarker and translational studies.
Basic statistical literacy and experience working with biostatisticians; familiarity with statistical software (R, SAS, STATA) desirable.
Proven ability to prepare abstracts, manuscripts and grant/funding applications for cardiovascular research.
Budget management and financial oversight for research studies; experience tracking costs and site invoicing.
Use of hospital electronic medical records (EMR) and practice in extracting clinical source data for research.

Soft Skills

Excellent verbal and written communication skills for interacting with patients, multidisciplinary teams, sponsors and regulatory bodies.
Strong organizational skills with meticulous attention to detail and documentation accuracy.
Leadership and team management skills, including mentoring junior researchers and coordinating cross-functional teams.
High ethical standards, patient-centered approach and sound clinical judgement in complex situations.
Problem-solving mindset and ability to prioritise in a dynamic clinical research environment.
Resilience and adaptability to manage competing clinical and research demands.
Strong interpersonal skills to build collaborative relationships with clinicians, industry partners and patient groups.
Time management and project planning skills to meet enrolment targets and study milestones.
Cultural sensitivity and ability to work with diverse patient populations and stakeholders.
Critical appraisal skills and curiosity to translate clinical observations into research questions.

Education & Experience

Educational Background

Minimum Education:

MBBS/MD or equivalent medical degree OR PhD in Cardiovascular Science/Biomedical Science plus clinical exposure.

Preferred Education:

MD with cardiology training (registrar/trainee) or MD-PhD; postgraduate qualification in Clinical Research (MSc, MPH) preferred.
Additional certifications in echocardiography, cardiac MRI or research methods are advantageous.

Relevant Fields of Study:

Cardiology / Internal Medicine
Clinical Research / Epidemiology / Biostatistics
Cardiovascular Science / Physiology
Biomedical Engineering (for device-focused research)
Translational Medicine / Molecular Cardiology

Experience Requirements

Typical Experience Range:

1–5 years of clinical research experience post-medical qualification; cardiology trainees often undertake this fellowship during registrar training.

Preferred:

Prior experience as a study coordinator, sub-investigator, or site lead on multicenter randomized controlled trials or device studies.
Demonstrated track record of publications, conference presentations, and involvement in protocol development or grant applications.
Experience with interventional cardiology, heart failure clinics, or arrhythmia/device services is highly desirable.
Proven competency in GCP-compliant trial conduct and experience liaising with sponsors and regulatory authorities.