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Key Responsibilities and Required Skills for Cardiac Clinical Research Intern

💰 $ - $

CardiologyClinical ResearchInternshipHealthcare

🎯 Role Definition

The Cardiac Clinical Research Intern supports cardiology investigators and clinical research teams by coordinating study visits, performing protocol-driven data collection and entry, assisting with regulatory documentation and IRB submissions, facilitating patient recruitment and informed consent under supervision, and contributing to the quality control of clinical trial data. This role provides experiential learning across clinical trial operations, cardiac diagnostics (ECG, echocardiography), biospecimen handling, and research governance, preparing interns for careers as Clinical Research Coordinators or further clinical training.

📈 Career Progression

Typical Career Path

Entry Point From:

  • Undergraduate student in biology, nursing, biomedical engineering, or public health
  • Recent graduate with bachelor's degree seeking clinical research experience
  • Pre-medical, nursing, or allied health student completing a practicum/internship

Advancement To:

  • Clinical Research Coordinator (CRC)
  • Clinical Trials Associate / Research Assistant II
  • Cardiology Research Specialist or Study Coordinator
  • Clinical Operations Associate or Project Manager (with experience)

Lateral Moves:

  • Data Coordinator / Clinical Data Analyst (research-focused)
  • Regulatory Affairs Associate
  • Patient Navigator or Clinical Care Coordinator

Core Responsibilities

Primary Functions

  • Assist principal investigators and study coordinators in the day-to-day operations of cardiac clinical trials, including screening, enrolling, and following up study participants in accordance with study protocols and GCP (Good Clinical Practice).
  • Conduct pre-screening chart reviews and eligibility assessments using electronic health records (EHR/Epic) to identify potential cardiac study candidates and document findings in screening logs.
  • Facilitate participant recruitment and retention activities: schedule visits, make reminder calls, coordinate transportation when needed, and maintain recruitment trackers to meet enrollment milestones.
  • Obtain and document informed consent under supervision, ensuring participants understand study procedures, risks and benefits, and privacy protections in accordance with IRB-approved consent forms and HIPAA regulations.
  • Collect clinical data during study visits: record vitals, perform or assist with ECG acquisition, perform basic cardiac assessments (e.g., 12-lead ECG setup), and document findings accurately in source documents.
  • Perform standardized measurements and specimen collection tasks as delegated (e.g., phlebotomy, processing and labeling blood/saliva samples, handling biospecimens per protocol and biorepository SOPs), maintaining chain-of-custody documentation.
  • Enter, clean, and reconcile study data in electronic data capture (EDC) systems such as REDCap or Medidata Rave, perform query resolution, and run source-to-CRF verification to ensure data integrity.
  • Maintain regulatory binders and trial documentation: file IRB approvals, informed consent documentation, delegation logs, training certificates (CITI), and protocol versions in the site regulatory file and eTMF as required.
  • Assist with adverse event (AE) and serious adverse event (SAE) documentation: collect necessary source data, complete AE/SAE forms, and escalate to study coordinators or PIs for timely reporting to sponsors and IRB.
  • Support study start-up activities including preparing study-specific materials, setting up study visit schedules, coordinating site initiation logistics, and liaising with vendors and imaging core labs.
  • Schedule and coordinate diagnostic testing (echocardiography, cardiac MRI, Holter monitors, stress tests) and ensure transfer of imaging/data to central core labs following protocol-specific instructions.
  • Participate in patient education by providing study-related instructions, documenting participant concerns, and coordinating clinical follow-up or referrals with the clinical care team as directed.
  • Conduct quality assurance checks and assist with internal monitoring visits, generating monitoring visit binders, responding to monitor queries, and implementing corrective actions recommended by monitors.
  • Support collection and entry of patient-reported outcomes (PROs) and validated cardiac questionnaires, administer standardized assessments, and ensure completeness of longitudinal follow-up measures.
  • Assist with protocol amendment implementation: update site documentation, track training requirements, and communicate changes to study staff to ensure ongoing compliance.
  • Prepare study-related materials and reports for weekly research meetings, compile recruitment metrics, enrollment dashboards, and regulatory status summaries for the research team.
  • Help manage investigational device or drug accountability logs when applicable to cardiac device trials: conduct inventory checks, document dispensation and returns, and ensure secure storage according to protocol.
  • Contribute to literature reviews and background research for protocol development, posters, and manuscript preparation; assist with reference management and drafting sections under supervision.
  • Participate in informed, HIPAA-compliant communication with treating clinicians, scheduling departments, and laboratory personnel to align clinical care and research procedures without disrupting standard patient care.
  • Shadow and support clinical trial monitors and research staff during site initiation visits, interim monitoring, and close-out visits to learn monitoring processes and regulatory expectations.
  • Maintain continuing education: complete required training modules (CITI, GCP, HIPAA, site-specific SOPs), document training in the delegation log, and apply learning to improve study conduct.
  • Collect and organize source documents, ensure accurate source data entries, and prepare redacted medical records or de-identified datasets for sponsor and IRB review in accordance with data privacy policies.
  • Track and manage study reimbursements and stipend distributions, prepare expense documentation for participant reimbursement programs, and coordinate with finance teams as needed.

Secondary Functions

  • Support ad-hoc data requests, run basic queries in REDCap or Excel, and produce summary tables and visualizations for research meetings.
  • Contribute to the organization's cardiac research strategy by providing insights from participant interactions, recruitment bottlenecks, and data quality trends.
  • Collaborate with cardiology clinical teams, imaging core labs, and external vendors to translate operational needs into executable study tasks.
  • Participate in study planning and sprint-style coordination meetings; support protocol timelines, task assignments, and follow-up on action items.
  • Assist with grant submission logistics, including assembling CVs, budgets, and documentation for investigator-initiated studies or institutional awards.
  • Help maintain a clean, organized workspace in clinic and research offices, manage study supplies, and ensure calibration and availability of research equipment.
  • Provide cross-coverage support for other cardiology studies during high-volume periods, ensuring continuity in participant contact and essential documentation.

Required Skills & Competencies

Hard Skills (Technical)

  • Working knowledge of Good Clinical Practice (GCP), HIPAA regulations, and IRB processes relevant to clinical research.
  • Experience or familiarity with electronic health records (EHR) systems—Epic preferred—for chart review and scheduling.
  • Hands-on experience with electronic data capture (EDC) systems such as REDCap, Medidata Rave, or similar platforms for data entry and query management.
  • Basic ECG acquisition skills and familiarity with 12-lead ECG procedures; ability to document and upload tracing files to study systems.
  • Experience with specimen handling and labeling, phlebotomy (if certified) or demonstrated training in biospecimen processing and cold-chain procedures.
  • Proficiency in Microsoft Office suite: Excel for data reconciliation and pivot tables, Word for reports, and PowerPoint for presentations.
  • Familiarity with clinical research documentation: regulatory binders, delegation logs, source documents, and adverse event reporting workflows.
  • Basic understanding of cardiac imaging modalities (echocardiography, cardiac MRI) and the process of transferring images/data to core labs.
  • Competence in patient-reported outcomes (PRO) collection and validated questionnaire administration.
  • Data quality assurance skills: source-to-CRF verification, query resolution, and the ability to reconcile discrepancies.
  • Basic statistical literacy and familiarity with data visualization tools (Excel, GraphPad, or Tableau) to assist with reporting.
  • Comfortable using secure file transfer tools and REDCap APIs or CSV exports for aggregated data pulls.

Soft Skills

  • Excellent verbal and written communication skills for interacting with patients, clinical staff, and study teams.
  • Strong organization and time-management skills; proven ability to manage multiple study tasks and maintain accurate documentation.
  • High attention to detail and commitment to data quality and protocol adherence.
  • Empathy and professional bedside manner for patient-facing responsibilities in a cardiology clinic or inpatient setting.
  • Team player with collaborative attitude; able to work effectively across multidisciplinary teams (physicians, nurses, lab staff, vendors).
  • Critical thinking and problem-solving skills to escalate issues and propose pragmatic solutions.
  • Adaptability and willingness to learn in a fast-paced clinical research environment.
  • Integrity and ethical judgment when handling confidential health information.
  • Initiative and self-motivation to take on assigned tasks and seek mentorship for professional growth.
  • Reliability and punctuality to support scheduled visits, monitoring, and coordinated study activities.

Education & Experience

Educational Background

Minimum Education:

  • Currently enrolled in or recently completed a Bachelor's degree in a relevant field (Biology, Nursing, Public Health, Biomedical Engineering, Psychology, or related disciplines).

Preferred Education:

  • Pursuing or completed advanced degree (MS, MPH, MSN, or pre-medical coursework) or clinical certification.
  • Coursework or certification in clinical research, human subjects protection (CITI), or phlebotomy is advantageous.

Relevant Fields of Study:

  • Nursing
  • Biology or Biomedical Sciences
  • Public Health / Health Sciences
  • Biomedical Engineering
  • Psychology / Behavioral Sciences
  • Clinical Research / Research Administration

Experience Requirements

Typical Experience Range:

  • 0–2 years (internship, volunteer, clinical shadowing, laboratory or research assistant roles)

Preferred:

  • 6+ months of prior clinical research exposure, volunteer work in a hospital/clinic, or laboratory experience.
  • Experience interacting with patients in a clinical environment, basic ECG or phlebotomy training, and familiarity with EDC/REDCap or EHR systems.
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