Clinical Research Coordinator I - Cardiology (CARE)

Clinical Research Coordinator I - Cardiology (CARE)

The Clinical Research Coordinator I is an intermediate level position that provides independent study coordination for simple and moderately complex clinical research studies such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies or under supervision provides study coordination for moderate complexity to high complexity clinical trials with supervision such as such as EFS and pivotal IDE/IND studies. Responsible for consent, screening for eligibility and identification of AES under minimal supervision. Completes subject follow ups, source documentation, device accountability and preparing for monitoring visits independently. The CRC I should be capable of independently performing tasks, making decisions, and consistently delivering accurate and high-quality work. They possess a moderate level of expertise across various skills and abilities within their function on the research team.

Clinical Coordination:

• May create a recruitment plan that addresses the needs of the study population.
• Demonstrates ability to screen participants for study eligibility & enroll with accuracy in various databases.
• Demonstrates ability to find and utilize information from EMR and databases/CTMS/EDC.
• Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.
• Understands protocol structure and how to interpret study requirements to ensure study compliance.
• Understands proper documentation techniques as outlined in the ICH-GCP guidelines.
• May complete P-card reimbursement to patients.
• Processes subject visit billing and tracking of invoiceable items.
• Schedules, assists with preparation, and attends study initiation meetings, audits, and monitor visits.
• Obtains informed consent from subject.
• Conducts all startup, active implementation, and closeout activities
• Assesses studies for execution and troubleshoots potential implementation issues.
• Demonstrates the ability to anticipate and mitigate the potential for protocol non-compliance.
• Triages subject concerns and issues appropriately.
• Performs moderately complex study procedures with accuracy.

Data Coordination:

• Enters data to complete forms (CRFs) on paper, databases, or EDCs.
• Demonstrates ability to resolve moderately complex queries (e.g., data error changed numerous values in EDC).
• Explains how to utilize information from the EMR and study databases.
• Demonstrates the ability to complete moderately complex data collection during study visits.
• Demonstrates the ability to document data in accordance with ALCOA-C principles.
• Administers surveys and questionnaires.
• Demonstrates ability to perform concomitant medications abstraction.
• Builds patient research study charts.
• Assists with collection of external medical records, CLIAs, CAPs, and radiology CDs as assigned.
• Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles.
• Demonstrates the ability to create CRFs, study documents, and tools.
• Knowledge of the elements and development of an effective corrective and preventive action plan (CAPA).
• Creates and manage databases.

Regulatory Coordination:

• Uses proper documentation techniques as outlined in the ICH-GCP guidelines.
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH-GCP guidelines.
• Assists Regulatory manager in submission and management of IRB applications.
• Demonstrates ability to identify Adverse Events (AEs), Serious Adverse Events (SAEs), and UP and understands how to report appropriately.
• Demonstrates ability to manage increasing levels of protocol complexity or volume efficiently.
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting.
• Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes.

Administrative Responsibilities:

• Provides other administrative support for study activity including scanning, filing, etc. of research documents; managing organization of research kits.
• Communicates with study participants such as sending study correspondence via mail or email.
• Schedules subjects for research visits and FU appointments.
• Checks study calendar for completion of study procedures.
• Manages study supply inventory.
• Utilizes documents and systems to track recruitment and retention of participants.
• Participates in regular study meetings.
• Provides logistic and regulation guidance to entry level employees on Federal and University policy and guidelines.
• Acts as a liaison or point of contact between investigators, research teams, sponsors, other universities, cooperative groups, other internal and external departments to get questions answered and issues resolve.

Training:

• Gains appropriate training & knowledge of EMR, CTMS, EDC, databases, etc. as assigned.
• Attends and participates in all training assigned to this level including CITI, GCP, HIPAA.
• 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.
• Attends and participates in all training assigned to this level.

Competency:

• Functional Knowledge: Demonstrates a strong understanding of the research subject matter specific to their role on the team.
• Problem Solving: Analyzes moderately complex situations and apply education, experience, judgment, and precedent to identify and implement effective solutions.
• Decision Making/Autonomy: Carries out research projects per guidelines and regulation 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: Summarizes and explains research information to others effectively.

Perform other responsibilities as assigned.

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 Clinical Research Coordinator may support task-oriented requirements within the broader context of clinical research coordination.

Minimum Qualifications:

• Bachelor's degree or equivalent in education and/or experience, plus 3 years of experience.
• Mastered competency of the specific responsibilities and duties from the CRC.
• Technical competency in areas such as regulatory requirements, data management, and study documentation.
• Experience in managing study-specific procedures, including patient eligibility screening, informed consent, and adverse event reporting.

Other Requirements:

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

Equal Opportunity Employer / Disability / Veteran

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