Key Responsibilities and Required Skills for Cardiac Clinical Research Assistant

🎯 Role Definition

The Cardiac Clinical Research Assistant (CCRA) performs day-to-day operational and study coordination tasks for cardiology-focused clinical trials and observational studies. Reporting to a Clinical Research Coordinator or Principal Investigator, the CCRA recruits and screens subjects, obtains informed consent, performs study-specific assessments (ECGs, vitals, phlebotomy), collects and processes specimens, enters and validates data in electronic data capture systems, supports regulatory documentation, and liaises with clinical teams, sponsors, and core labs to ensure protocol fidelity, patient safety, and data quality. This role requires knowledge of GCP, human subjects protections, cardiac procedures, and strong organizational and communication skills.

📈 Career Progression

Typical Career Path

Entry Point From:

Research Assistant / Lab Technician (basic clinical research experience)
Cardiac/Telemetry Nurse or Nurse Technician
Medical Assistant with research exposure

Advancement To:

Clinical Research Coordinator (CRC)
Clinical Research Associate (CRA)
Study Coordinator / Clinical Trials Manager
Research Project Manager or Clinical Operations Lead

Lateral Moves:

Regulatory Affairs Specialist
Clinical Data Coordinator / Data Manager
Patient Recruitment & Outreach Specialist

Core Responsibilities

Primary Functions

Recruit, screen, and pre-screen potential study participants using protocol-defined inclusion/exclusion criteria by performing chart reviews, telephone prescreening, and in-person screening to maximize appropriate enrollment for cardiac clinical trials.
Obtain informed consent in accordance with IRB-approved protocols and Good Clinical Practice (GCP), ensuring subjects understand study procedures, risks, benefits, and data privacy protections (HIPAA compliance).
Perform protocol-specific cardiac assessments including 12-lead ECG acquisition, rhythm strip capture, orthostatic vital signs, and symptom inventories; ensure ECGs are performed to study standards and uploaded to the electronic repository or core lab.
Conduct basic cardiac-focused clinical procedures such as phlebotomy for biomarker collection, processing and aliquoting blood/saliva/urine samples per protocol, and prepare and ship specimens under cold-chain or ambient conditions to central laboratories.
Collect, document, and maintain accurate source documents (medical records, case report forms, screening logs) and ensure timely, auditable source-to-CRF traceability for site monitoring and regulatory review.
Enter, query, and clean study data in electronic data capture systems (EDC) such as REDCap, Medidata Rave, or Oracle Clinical; manage query resolution and data discrepancy reconciliation with study monitors and data managers.
Monitor and report adverse events (AEs) and serious adverse events (SAEs) promptly per protocol and sponsor/IRB requirements, assisting the PI with safety assessments and reporting timelines.
Maintain regulatory binder, IRB submissions, informed consent templates, protocol amendments, and delegated personnel logs; prepare materials for continuing review and ensure all regulatory documentation is current and audit-ready.
Coordinate study visits including scheduling, sending visit reminders, arranging echocardiography/angiography/CT/MRI appointments, and escorting participants through visits to ensure protocol adherence and participant retention.
Facilitate site initiation, sponsor and CRO monitoring visits, and audits by preparing required documentation, responding to site action items, and implementing corrective and preventive actions (CAPAs).
Support protocol implementation by reviewing protocol amendments, updating study procedures, revising checklists, and training staff on new requirements to maintain compliance with regulatory standards.
Maintain and calibrate study equipment (ECG machines, blood pressure monitors, centrifuges, freezers), keep equipment logs, and coordinate maintenance or replacement to ensure uninterrupted study operations.
Liaise with multidisciplinary clinical teams — cardiologists, research nurses, coordinators, lab personnel, pharmacy, and imaging core labs — to coordinate specimen flow, imaging reads, and medication dispensation as required by the protocol.
Track and reconcile study supplies and inventory (consent forms, lab kits, CRFs, shipping materials), manage ordering processes, and monitor budgeted supply usage to support fiscal stewardship of trial resources.
Assist with source document abstraction and data collection for endpoint adjudication committees, clinical events committees (CECs), or DSMBs (Data Safety Monitoring Boards) and support preparation of adjudication packets.
Support patient retention and follow-up through outreach, scheduling long-term follow-up visits, collecting phone- or electronic-based outcome data, and maintaining longitudinal contact logs.
Participate in training sessions and competency assessments for new hires and study-specific personnel, maintaining a documented training matrix and competency records for delegated tasks.
Assist with study start-up activities including feasibility assessments, site qualification visits, contracting support (billing grids), and development of site-specific study manuals and visit checklists.
Prepare study status reports, enrollment metrics, and regulatory trackers for the PI and study leadership; contribute to internal newsletters, investigator meetings, and sponsor status updates to highlight enrollment and data quality.
Support manuscript preparation, abstract submission, and presentation materials by compiling datasets, creating tables/figures, and coordinating with investigators and biostatisticians for accurate reporting of cardiac trial outcomes.
Implement participant safety procedures, infection control, and emergency response protocols (CPR/AED readiness) during study activities and escalate clinical concerns promptly to the PI or on-call cardiology team.
Perform detailed chart reviews and source verification to ensure baseline and follow-up endpoints (e.g., heart failure hospitalizations, revascularization events, biomarker changes) are correctly captured and adjudicated.
Maintain confidentiality of participant information and adhere to institutional and sponsor privacy and security requirements for handling protected health information (PHI).
Contribute to continuous quality improvement initiatives by identifying workflow bottlenecks, suggesting process improvements, and participating in SOP revisions to increase operational efficiency and data integrity.
Support remote and decentralized trial activities such as telehealth visits, home health phlebotomy coordination, wearable device deployment and data collection, and integration of remote ECG/wearables per study design.
Assist with study close-out activities: final query resolution, shipping final study samples, archiving regulatory documents, and preparing final close-out reports to ensure compliance with sponsor and institutional requirements.

Secondary Functions

Develop and distribute participant-facing recruitment materials, scripts, and outreach letters in collaboration with community engagement teams to boost enrollment for cardiology trials.
Maintain and update recruitment logs, referral databases, and prescreening tools; coordinate with clinic front-desk staff to identify potential participants from ambulatory cardiology clinics and inpatient services.
Support budgeting and invoicing tasks by tracking site expenses, processing study-related reimbursements and participant stipends, and documenting time-and-effort for grant accounting.
Participate in interdisciplinary research meetings and contribute operational perspectives to study design, feasibility assessments, and protocol refinement to optimize participant flow and data collection.
Assist regulatory staff with IRB amendment drafts, safety reporting submissions, and coordination of continuing reviews to support timely regulatory approvals and study conduct.
Provide ad-hoc support for data exports, basic data summaries, and reports for study leadership using Excel or institutional reporting tools to inform enrollment strategies and operational decision-making.
Coordinate vendor relationships with central labs, ECG core labs, imaging vendors, and courier services to ensure on-time sample pick-up, deliverables, and adherence to study-specific processing timelines.
Support quality assurance activities including internal audits, mock monitoring visits, and documentation of corrective actions to ensure continuous compliance with regulatory and sponsor expectations.
Facilitate community engagement events, patient advisory board meetings, and investigator-initiated outreach to improve trial diversity and retention in cardiovascular research.
Manage and organize electronic and paper files for rapid retrieval during monitoring, audits, or site inspections and maintain systematic archiving practices according to institutional policies.

Required Skills & Competencies

Hard Skills (Technical)

Clinical trial operations and coordination for cardiology studies (recruitment, screening, consenting, visit conduct).
Proficient use of Electronic Data Capture (EDC) systems such as REDCap, Medidata Rave, Oracle Clinical, or similar for data entry, query management, and source verification.
Strong working knowledge of Good Clinical Practice (GCP), IRB submission processes, FDA regulations applicable to human subjects research, and HIPAA privacy rules.
ECG acquisition and basic interpretation skills, familiarity with 12-lead ECG machines and digital upload procedures to core labs or EDC.
Phlebotomy skills and specimen processing (centrifugation, aliquoting, labeling, cold chain shipping) with adherence to chain-of-custody and biospecimen SOPs.
Adverse event and serious adverse event reporting practices, safety monitoring workflows, and escalation procedures to PIs and DSMBs.
Experience with regulatory binder maintenance, delegation logs, training matrices, and document control for audit readiness.
Proficiency with clinical documentation standards, CRF completion, source-to-CRF reconciliation, and query resolution methodology.
Familiarity with clinical scheduling systems, electronic medical records (Epic, Cerner), and integration of clinic workflows with research visits.
Basic data manipulation and reporting skills using Microsoft Excel (pivot tables, VLOOKUP), and exposure to statistical packages (SAS, R, SPSS) is a plus.
Knowledge of wearable cardiac monitors, mobile health devices, or remote ECG technology and associated data capture/validation processes.
Experience with billing compliance, clinical trial budgeting, and tracking study-related costs is advantageous.

Soft Skills

Exceptional attention to detail and accuracy in data capture, documentation, and regulatory adherence.
Strong verbal and written communication skills for interacting with participants, investigators, sponsors, and regulatory bodies.
Excellent organizational and time-management abilities to coordinate multiple study visits, deadlines, and competing tasks.
Patient-centered approach with empathy, cultural sensitivity, and the ability to build rapport and maintain participant trust.
Problem-solving mindset and resourcefulness to resolve operational issues, enrollment barriers, and data discrepancies.
Team player who collaborates effectively across clinical, laboratory, and administrative teams.
Adaptability and flexibility to operate in a fast-paced clinical research environment with shifting priorities.
Ethical judgment and integrity in handling confidential patient data and reporting adverse events.
Initiative to proactively identify process improvements and implement practical solutions that improve study performance.
Resilience and stress tolerance for managing high-volume recruitment periods and time-sensitive regulatory activities.

Education & Experience

Educational Background

Minimum Education:

Bachelor's degree in Nursing, Biology, Health Sciences, Biomedical Science, Public Health, or related field; or equivalent clinical experience (e.g., RN, Medical Assistant with research training).

Preferred Education:

Bachelor of Science in Nursing (BSN), Clinical Research Certification (SoCRA, ACRP), or Master's degree in Clinical Research, Public Health, or related discipline.

Relevant Fields of Study:

Nursing
Biology / Biomedical Sciences
Public Health / Epidemiology
Clinical Research / Health Sciences
Cardiovascular Physiology

Experience Requirements

Typical Experience Range: 0–3 years (entry-level with relevant clinical or research exposure) up to 3–5 years for more independent roles.

Preferred: 1–3 years of direct experience supporting cardiology clinical trials or cardiovascular research studies, demonstrated experience with EDC systems (REDCap/Medidata), ECG acquisition and basic interpretation, phlebotomy and biospecimen handling, and familiarity with IRB/GCP/AE reporting. Prior experience working in an academic medical center or research hospital and certifications (CPR, clinical research certifications) are desirable.