Clinical Research Coordinator I - Cardiology

The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to departmental budgets, qualifications, experience, education, licenses, specialty, and training. The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.

Position Summary

The Clinical Research Coordinator I (CRC I) is responsible for independently coordinating simple to moderately complex clinical research studies, including registries, retrospective data reviews, and long-term follow-up studies. Under supervision, they may assist with higher complexity trials such as EFS and pivotal IDE / IND studies. Responsibilities include screening and consenting participants, managing study procedures, documenting data, device accountability, and preparing for monitoring visits. Additionally, the CRC I may assist with laboratory animal studies involving mice with cardiac arrhythmias.

Responsibilities

CLINICAL COORDINATION

• May create a recruitment plan that addresses the needs of the study population.
• Screen and enroll participants, ensuring accuracy in databases.
• Find and utilize information from EMR and databases / CTMS / EDC.
• Execute study procedures per protocol requirements.
• Conduct subject follow-ups and manage study compliance.
• Assist with laboratory animal studies on mice with arrhythmias such as performing ECG and breeding, genotypying
• Utilize proper documentation techniques as outlined in the ICH-GCP guidelines.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Obtain informed consent from subjects and ensure proper documentation.
• Conduct all startup, active implementation, and closeout activities.
• Assess studies for execution and troubleshoot potential implementation issues.
• Anticipate and mitigate the potential for protocol non-compliance and escalate issues as necessary.
• Triage subject concerns and issues appropriately.

DATA COORDINATION

• Enters and manage data to complete forms (CRFs) on paper, databases, or EDCs.
• Resolve moderately complex queries (e.g., data error changed numerous values in EDC).
• Explain how to utilize information from the EMR and study databases.
• Complete moderately complex data collection during study visits.
• Document data in accordance with ALCOA-C principles.
• Administer surveys and questionnaires.
• Perform concomitant medications abstraction.
• Build patient research study charts.
• Assist with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.
• Contribute to the development of processes and tools to capture data in accordance with ALCOA- C principles.
• Create CRFs, study documents, and tools.
• Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA).
• Create and manage databases.

REGULATORY COORDINATION

• Use proper documentation techniques and maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Assist Regulatory manager in submission and management of IRB applications.
• Identify Adverse Events (AEs), Serious Adverse Events (SAEs), and UP and report appropriately.
• Manage increasing levels of protocol complexity or volume efficiently.
• Demonstrate an understanding of the elements of subject safety, related documentation, and reporting; recognize situations requiring prompt escalation and act to minimize risks.
• Demonstrate an understanding of Investigational products development process and applies key regulatory requirements to control these processes.

ADMINISTATIVE

• Provide administrative support for study activity including scanning, filing, etc. of research documents; manage organization of research kits.
• Communicate with study participants, such as sending study correspondence via mail or email.
• Schedule subjects for research visits and follow-up appointments.
• Check the study calendar for completion of study procedures.
• Manage study supply inventory.
• Utilize documents and systems to track recruitment and retention of participants.
• Participate in regular study meetings.
• Provide logistic and regulatory guidance to entry-level employees on Federal and University policy and guidelines.
• Act as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, and other internal and external departments to get questions answered and issues resolved.

TRAINING

• CITI, GCP, HIPAA
• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Attends and participates in all training assigned to this level.
• Understands the disease process per program.
• Participates in trainings specifically for maintaining certification as a Clinical Research Professional
• Provides training and mentorship for CRC clinical research staff on communication and teamwork best practices.

COMPETENCY

• Functional Knowledge : Demonstrate a strong understanding of the research subject matter specific to their role on the team.
• Problem Solving : Analyze moderately complex situations and apply education, experience, judgment, and precedent to identify and implement effective solutions.
• Decision Making / Autonomy : Carry out research projects per guidelines and regulations with limited supervision, collaborating both independently and with the Principal Investigator (PI) and Clinical Research Manager. Requires a moderate degree of initiative and independent judgment.
• Communication Skills : Summarize and explain research information to others effectively.

Perform other responsibilities as needed.

Please note that specific responsibilities may vary based on the needs of your unit or team. Certain units may require a greater focus on clinical, data, regulatory, or other specific needs. The role of a Clinical Research Coordinator may support task-oriented requirements within the broader context of clinical research coordination.

Minimum Qualifications

• Bachelor's degree in a specific research field or a related discipline and at least three (3) years of related experience or equivalent in education and training.
• Technical competency in areas such as regulatory requirements, data management, and study documentation.

Other Requirements

• Must successfully complete systems and compliance training requirements.

Participation in Medical Surveillance Program :

• Work with Laboratory Animals
• Contact with Patients

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.