Key Responsibilities and Required Skills for Cardiac Clinical Research Technician

🎯 Role Definition

The Cardiac Clinical Research Technician (CRT) is an essential clinical research team member who supports cardiology studies from screening and enrollment through study completion. The CRT performs patient-facing procedures (ECGs, vital signs, phlebotomy), collects and processes biologic samples, ensures accurate source documentation and eCRF entry, monitors safety and adverse events, and maintains regulatory and study-specific compliance (IRB, GCP, HIPAA). This position works closely with Principal Investigators, study coordinators, clinical research nurses, lab staff, and monitoring organizations to deliver high-quality, protocol-compliant data for cardiac clinical trials, device studies, pharmacologic interventions, and observational cardiology research.

Key SEO/LLM keywords integrated: Cardiac Clinical Research Technician, cardiology clinical trials, ECG acquisition, phlebotomy, GCP compliance, IRB reporting, eCRF data entry, adverse event monitoring, participant recruitment.

📈 Career Progression

Typical Career Path

Entry Point From:

Clinical Research Assistant / Research Assistant (cardiology or general clinical research)
Medical Assistant or Patient Care Technician with phlebotomy/ECG experience
Phlebotomist / EKG technician / Cardiac Sonography trainee

Advancement To:

Clinical Research Coordinator / Senior Clinical Research Coordinator (Cardiology)
Research Nurse (if licensed RN with additional training)
Clinical Trial Manager / Study Manager (Cardiac portfolio)
Clinical Research Supervisor or Site Lead for cardiac studies

Lateral Moves:

Cardiac Sonographer / Echo Lab Technician (with additional certification)
Regulatory Affairs Associate (transition with regulatory experience)
Laboratory Processing Technician / Biobanking Specialist

Core Responsibilities

Primary Functions

Conduct participant screening and eligibility assessments according to study protocols and inclusion/exclusion criteria, documenting findings in source documents and notifying the PI for enrollment decisions; optimize subject flow to maximize retention and protocol adherence.
Perform informed consent discussions and document consent under the direction of the PI or designated study staff; educate participants on study procedures, risks, benefits, and visit schedules while ensuring HIPAA-compliant communication.
Acquire high-quality 12-lead ECGs, ambulatory rhythm monitor setups (e.g., Holter/event monitors), and other cardiac monitoring per protocol specifications, perform immediate quality checks, and transmit data to core labs or CROs as required.
Perform phlebotomy and venipuncture for clinical trial sample collection, label and process specimens (centrifugation, aliquoting), prepare frozen or ambient shipments following protocol and biohazard regulations, and maintain accurate chain-of-custody logs.
Collect vital signs (BP, HR, respiratory rate, oxygen saturation, weight), document baseline and follow-up measures, and escalate clinically significant findings to the PI or study physician immediately.
Assist with study-specific cardiac procedures (exercise stress testing prep, treadmill monitoring, telemetry hookup) following safety and protocol guidelines; coordinate with cardiology services for imaging or invasive procedures when needed.
Administer study-related point-of-care testing (glucose, INR, pregnancy tests) and document results in source documents and eCRF; ensure quality control and calibration of devices.
Maintain accurate, contemporaneous source documentation and complete electronic case report forms (eCRFs/EDC) in systems such as REDCap, Medidata Rave, or Oracle Clinical, resolving queries in collaboration with data management.
Monitor and document concomitant medications, medical history updates, and protocol deviations; support timely reporting and corrective actions to preserve data integrity and regulatory compliance.
Identify, document, and report adverse events (AEs), serious adverse events (SAEs), and unanticipated problems per protocol, sponsor guidelines, and IRB requirements; prepare event narratives and assist with follow-up assessments.
Prepare and maintain regulatory files (Study Binder, Delegation Log, ICF versions, training records) to meet GCP and sponsor audit/monitoring expectations; support study start-up, site initiation, and close-out activities.
Coordinate and host sponsor and CRO monitoring visits; prepare monitoring materials, provide accurate source documentation, and resolve monitoring findings in a timely manner.
Manage investigational product (IP) handling when applicable — inventory control, temperature monitoring, dispensing per protocol, accountability logs, and returns/destruction as required by study and pharmacy SOPs.
Facilitate participant scheduling, reminders, and follow-up to improve retention; proactively contact participants for upcoming visits, missed appointments, and study milestones while maintaining participant safety and data completeness.
Support cardiac imaging/data transfer workflows — coordinate ECG, echocardiogram, cardiac MRI, or core lab submissions and verify that imaging is de-identified and meets submission standards.
Conduct quality assurance checks on source data, consent forms, regulatory documents, and laboratory logs; escalate discrepancies and implement corrective/preventive actions under study leadership.
Train and mentor junior research staff and clinical volunteers on protocol procedures, phlebotomy, ECG acquisition, and GCP basics; maintain current competency records and training documentation.
Participate in study meetings, investigator meetings, and protocol review sessions; provide operational feedback on recruitment strategies, visit flows, and operational feasibility.
Maintain biosafety and infection control practices in the clinic and laboratory areas; handle biohazardous materials and sharps according to institutional and regulatory SOPs.
Collaborate with interdisciplinary teams (PI, research nurses, lab personnel, billing/compliance) to ensure appropriate study billing, research-eligible procedure identification, and separation of research vs. clinical care costs.
Implement recruitment strategies including screening medical records, coordinating with clinic staff, and preparing IRB-approved recruitment materials to meet enrollment targets while protecting patient privacy.
Support sample tracking and participation in translational research workflows (biobanking, genomics, proteomics) ensuring informed consent covers future use and material transfer agreements are followed.

Secondary Functions

Assist site staff with study start-up tasks such as preparing study-specific SOPs, delegating responsibilities, and participating in feasibility assessments and budget/time estimates.
Provide ad-hoc data exports and light data reconciliation support for interim analyses; collaborate with data management to address data queries and prepare datasets for monitoring.
Participate in root cause analyses for recurring monitoring findings and support implementation of process improvements to streamline visit flow and reduce query rates.
Help maintain equipment inventories and coordinate preventive maintenance for ECGs, centrifuges, and other study-critical devices; escalate equipment failures to biomedical engineering and document downtime.
Support quality improvement initiatives, including operating procedure optimization, recruitment funnel analytics, and patient experience enhancements to boost retention and site performance.

Required Skills & Competencies

Hard Skills (Technical)

Proficient ECG acquisition and interpretation basics (12-lead ECG setup, rhythm identification for quality control).
Certified phlebotomy/venipuncture skills and specimen processing (centrifugation, aliquoting, frozen storage).
Experience with electronic data capture (EDC/eCRF) systems such as REDCap, Medidata Rave, or Oracle Clinical; accurate and timely eCRF entry and query resolution.
Strong knowledge of Good Clinical Practice (GCP), FDA regulations, and IRB processes; familiarity with HIPAA and patient privacy best practices.
Competent in AE/SAE identification, documentation, and expedited reporting procedures in accordance with sponsor and regulatory requirements.
Experience with investigational product accountability, temperature monitoring, and clinical trial pharmacy coordination.
Competence with basic cardiac research procedures: ambulatory monitor setup, treadmill/stress test support, telemetry hookup, and cardiac imaging coordination.
Proficiency in Microsoft Office (Excel for tracking logs, Word for narratives, Outlook/calendar management) and ability to produce audit-ready documentation.
Specimen shipping knowledge (IATA/UN3373) and appropriate labeling/packaging for biological samples.
Familiarity with clinical workstation integration and medical record systems (Epic, Cerner) to screen and document clinical encounters.

Soft Skills

Strong patient-facing communication, cultural sensitivity, and ability to explain complex study procedures in lay terms to potential participants.
Excellent attention to detail and organizational skills to maintain study documentation, regulatory binders, and sample inventories.
Critical thinking and problem-solving skills to triage safety signals, reconcile data queries, and implement process improvements.
Time management and prioritization to coordinate multiple concurrent study visits and meet enrollment targets.
Teamwork and collaboration across multidisciplinary teams (PI, nurses, lab techs, CROs) with a proactive, service-oriented mindset.
Adaptability to evolving protocol amendments, sponsor requirements, and fast-paced clinical environments.
Professionalism under stress and ability to escalate patient safety concerns promptly.
Teaching and mentorship skills to onboard new research staff and ensure consistent protocol execution.
High ethical standards and commitment to maintaining participant confidentiality and data integrity.
Customer-service orientation when interacting with patients, families, and clinic staff to facilitate smooth study participation.

Education & Experience

Educational Background

Minimum Education:

High school diploma or GED plus relevant clinical certifications (phlebotomy, EKG technician, Medical Assistant) OR
Associate degree in a health-related field (Allied Health, Biomedical Technician, Clinical Research) with hands-on clinical experience.

Preferred Education:

Bachelor's degree in Nursing, Biology, Biomedical Sciences, Clinical Research, Exercise Physiology, or a related health/science discipline.
Additional certifications preferred: Clinical Research Professional (CCRA/CRC), GCP certification, BLS (Basic Life Support).

Relevant Fields of Study:

Nursing
Biomedical Sciences
Clinical Research / Clinical Trials Management
Exercise Physiology / Kinesiology
Medical Assisting / Allied Health

Experience Requirements

Typical Experience Range: 1–4 years of direct clinical research support experience or equivalent clinical laboratory/clinic experience in cardiology or internal medicine, including documented phlebotomy and ECG experience.

Preferred:

2+ years supporting cardiology clinical trials or device studies with demonstrated experience in subject screening, consenting, ECG acquisition, specimen handling, and regulatory documentation.
Prior experience with EDC systems (REDCap, Medidata), investigator site files, and interaction with sponsors/CROs during monitoring visits.
Demonstrated track record of recruitment and retention in outpatient or inpatient cardiac research settings.