Key Responsibilities
Clinical and Research Coordination

• Coordinates the recruitment, screening, consent, and enrollment of eligible participants into the natural history study.
• Oversees scheduling and execution of research visits, including ECGs, cardiac imaging, blood draws, exercise testing, cardiac imaging and blood sample collection. Patients over 18 may elect to undergo a right heart catheter and myocardial biopsy.
• Conducts structured interviews and standardized questionnaires to capture detailed medical and family histories.
• Ensures the timely completion of study case report forms and source documentation in compliance with institutional and sponsor guidelines.

Nursing and Patient Care

• Performs study-related clinical assessments and procedures within scope of nursing practice (e.g., vital signs, ECG acquisition, specimen handling).
• Monitors participant safety and well-being throughout study activities; promptly reports and documents adverse events.
• Provides education to participants and families regarding study procedures, follow-up requirements, and genetic counseling resources.
• Maintains strict adherence to institutional infection control, patient confidentiality, and research safety standards.

Data and Regulatory Compliance

• Maintains study documentation and research records in accordance with institutional policy, sponsor requirements, and federal regulations (IRB, FDA, HIPAA).
• Participates in internal audits, data quality reviews, and monitoring visits.
• Supports the preparation of regulatory submissions, amendments, and annual reports.
• Collaborates with the research and biostatistics teams to ensure data completeness and integrity.

Collaboration and Communication

• Serves as a central point of contact for study participants, investigators, referring clinicians, and external collaborators.
• Participates in team meetings, case reviews, and protocol development discussions.
• Contributes to manuscripts, abstracts, and presentations summarizing study findings as appropriate.

Minimum Qualifications
Education:

• Bachelor’s degree in nursing (BSN) required; Master’s Degree (MSN) preferred.

Experience:

• Minimum of two to three years of relevant clinical or research nursing experience, preferably in cardiology or inherited disease research.
• Demonstrated knowledge of Good Clinical Practice (GCP), research ethics, and IRB processes.
• Proficiency in medical record systems (e.g., Epic) and electronic data capture tools (e.g., REDCap).
• Experience working in cardiovascular genetics or inherited arrhythmia syndromes (e.g., ARVC, HCM, LQTS).
• Familiarity with natural history or registry-based clinical studies.
• Prior experience coordinating NIH- or industry-sponsored research.

License/certifications:

• MA RN license required.
• BLS certification and CITI training.

Please note: During a public health emergency, individuals in this role may be expected to take on additional duties to respond to organizational needs.