Clinical Research Coordinator, Cardiology

Job Title: Clinical Research Coordinator - Cardiology

Position Summary

Entry-level position providing coordination and administrative support for clinical research projects in Cardiology, under supervision.

Key Responsibilities

Clinical Coordination

• Screen participants for study eligibility and enroll them accurately.
• Utilize information from EMR, databases, CTMS, and EDC.
• Understand and execute study protocol requirements and procedures.
• Interpret study protocols to ensure compliance.
• Maintain proper documentation as per ICH-GCP guidelines.
• Complete P-card reimbursement for patients.
• Track subject visit billing and invoiceable items.
• Assist in study initiation meetings, audits, and monitoring visits.
• Perform simple study procedures accurately.
• May obtain informed consent from participants.

Data Coordination

• Enter data in CRFs, databases, or EDCs.
• Resolve simple data queries.
• Extract and utilize information from EMR and study databases.
• Complete basic data collection during study visits.
• Document data according to ALCOA-C principles.
• Administer surveys and questionnaires.
• Perform concomitant medication abstraction.
• Build patient research study charts.
• Collect external medical records, CLIAs, CAPs, and radiology CDs as assigned.

Regulatory Coordination

• Maintain documentation following ICH-GCP guidelines.
• Work with regulatory support to collect essential documents and maintain regulatory binders (CVs, MD licenses, lab certifications, IRB rosters, lab norms, etc.).
• Assist the Regulatory Manager in IRB submissions and management.
• Identify and report Adverse Events (AEs), Serious Adverse Events (SAEs), and other safety concerns appropriately.

Administrative Support

• Provide administrative support, including scanning, filing, and organizing research documents.
• Manage research kit organization.
• Communicate with study participants via mail or email.
• Schedule research visits and follow-up appointments.
• Monitor study calendars for procedure completion.
• Manage study supply inventory.
• Track participant recruitment and retention.
• Participate in regular study meetings.
• Process payments and reimbursements for participants.
• Provide logistic and regulatory guidance on Investigator-Initiated Studies.
• Act as a liaison between investigators, research teams, sponsors, universities, and internal/external departments.

Training

• Complete required training in CITI, GCP, and HIPAA.
• Gain knowledge of EMR, CTMS, EDC, and other relevant databases.
• Learn and apply available technology and systems to job responsibilities.
• Acquire disease-specific knowledge relevant to assigned programs.
• Attend and actively participate in all assigned training.

Requirements & Tech Stack

• EDC
• Redcap
• CTMS
• EMR
• ICH-GCP guidelines
• ALCOA-C principles
• CITI
• GCP
• HIPAA

Qualifications

Minimum Qualifications

• Bachelor’s degree or equivalent in education, training, and experience.
• Perform other responsibilities as required.

Preferred Qualifications

• At least two years of related experience
• Knowledge of university policies and procedures
• Basic knowledge and understanding of clinical research processes, regulations, and the role of a Clinical Research Coordinator (CRC)

Other Requirements

• Participation in the medical surveillance program
• Contact with patients and/or human research subjects
• Potential bloodborne pathogen exposure
• Successful completion of applicable compliance and systems training requirements