Clinical Research Coordinator - Cardiology

Columbia University Irving Medical Center is seeking an entry-level Clinical Research Coordinator to provide supervised coordination and administrative support for cardiology clinical research projects. The role involves participant screening and enrollment, clinical research data entry and abstraction, regulatory documentation, study visit scheduling, participant communication, and support for monitoring visits and audits.

Responsibilities

Screen participants for study eligibility and enroll them accurately in various databases

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

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

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

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 to ensure compliance with university and federal guidelines

Act as a liaison between investigators, research teams, sponsors, universities, and internal/external departments to resolve issues

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

Preferred

At least two years of related experience

Knowledge of university policies and procedures

Related Experience

University Policies

Procedures Knowledge

Benefits

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.

Company

Academic medical center providing patient care, research, and education.

New York, New York, USA

https://www.cuimc.columbia.edu/

Founded in 1767

10001+ employees

Qualifications

Bachelor's degree or equivalent in education, training, and experience

Basic knowledge and understanding of clinical research processes, regulations, and the role of a Clinical Research Coordinator (CRC)

At least two years of related experience

Knowledge of university policies and procedures

Required skills

Clinical Research Coordination, Clinical Research Processes, Clinical Research Regulations, Medical Terminology

Preferred skills

At least two years of related experience, Knowledge of university policies and procedures

Experience

2+ years