Clinical Research Coordinator I - Cardiology
7 days ago
New York
• Job Type: Officer of Administration, • Regular/Temporary: Regular, • Hours Per Week: 35 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., • 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)., • 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., • 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., • 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, • 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. 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., • Must successfully complete systems and compliance training requirements., • Participation in Medical Surveillance Program:, • Work with Laboratory Animals Columbia University is committed to the hiring of qualified local residents.