Clinical Research Manager I - Cardiology

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $78,000 - $87,000 annual

Position Summary

The Clinical Research Manager I (CRM I) oversees and coordinates the execution of clinical research studies and trials conducted to evaluate the safety, efficacy, and effectiveness of new medical treatments, drugs, devices, and/or interventions. The CRM I plays a vital role in ensuring that clinical trials are conducted ethically, safely, and in compliance with regulatory guidelines. The CRM I supervises clinical research coordinators and ensures accountability to Cardiology Research guidance documents and standard operating procedures.  The CRM I develops processes, procedures, tools, and training to enhance clinical research activities.

Responsibilities

Team Management and Communication:

• Supervise the research team, providing guidance, support, and performance feedback. Ensure adherence to Cardiology Research policies and procedures.
• Assign tasks and responsibilities to team members, ensuring that work is distributed effectively and fairly. Assign studies to coordinators based on workload and study progress.
• Maintain consistency in the shared drive across studies, Monitor and update Master logs regularly, coordinate monthly emails from PIs to research team members, Utilize appropriate systems, such as TEAMS, for efficient coordination.
• Convey goals, expectations, and feedback to team members clearly. Communicate unit activities on a bi-weekly basis and as needed to the Director and Assistant Director.
• Develop and implement practical solutions for various challenges and problems within team or projects. Immediately communicate and consult with the Director or Assistant Director on compliance-related matters.
• Efficiently manage time and prioritize tasks to meet deadlines and achieve goals. Manage coordinator schedules, track time off, and review/approve timesheets.
• Conduct performance reviews and provide constructive feedback to team members. Maintain metrics on study activities conducted by coordinators.
• Build positive relationships with team members and colleagues and foster a healthy work environment.
• Provide training to research staff and investigators to ensure proper implementation of the study protocol and compliance with regulations.

Study Management Coordination and Oversight:

• Complete site qualification visits for new studies, organize and schedule site initiation visits (SIV) and facilitate the rollout of new studies, ensure regulatory documents are in compliance with sponsor requirements in order to activate, develop source documents based on protocol and case report forms (CRFs) to ensure accurate data capture, Assist the primary Research Coordinator (RC) with the initial delegation of authority (DOA) process, facilitate communication between coordinators and principal investigators (PIs), communicate new protocols to outpatient clinic areas and inpatient locations, highlighting protocol deviations from standard of care (SOC) and potential impact on clinical workflow, ensure proper storage and handling of research products and maintain inventory.
• Assist with start-up budget review, ensure RCs are updating CTMS and invoiceable, ensure accurate billing for study-related activities and reconcile NYP Blue Bills vs budget.
• Facilitate monitoring access to the electronic medical record system (EPIC). Ensure smooth remote monitoring processes and address findings from monitoring visits. Review monitoring reports and queries, ensuring timely resolution of action items by Research Coordinators.
• Implement quality control measures to maintain the integrity and validity of data collected during the study. Conduct quality assurance activities, including post-consent calls, inclusion/exclusion verification, accurate and timely data entry, and AE reporting. Gather study-specific protocol deviations and develop preventive and corrective action plans s. Address major protocol deviations in collaboration with the PI and research leadership.
• Develop new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. Collaborate with research physicians and coordinators to develop strategies to maximize patient enrollment in clinical trials and troubleshooting.
• Identify noncompliance concerns, assess cause, create corrective action plans, and implement independently under supervision from the director.
• Conduct quality assurance audits.

Learning and Development:

• Participate in business and management learning opportunities.
• Present at conferences and seminars as needed.
• Stay updated with industry trends, management techniques, and best practices to enhance managerial abilities.
• Focus on developing leadership qualities such as motivating others, inspiring teamwork, and leading by example.
• Seek mentorship, attend workshops or training sessions, and be open to feedback.
• Demonstrate an initiative-taking attitude and a willingness to learn.
• Perform other responsibilities as needed.

**Responsibilities may vary based on the specific needs of the unit or team. Some units/teams may require a proportionate focus on clinical, data, regulatory, or other specific needs. The Clinical Research Coordinator position will primarily support task-oriented needs.

Minimum Qualifications

• Bachelor’s degree or equivalent in education, training, and experience, plus 4-6 years of related experience.

Preferred Qualifications

• Master’s degree preferred.

Other Requirements

• Previous experience in clinical research coordination.
• Strong knowledge of clinical research protocols and regulations.
• Excellent organizational and time management skills.
• Proficiency in data management systems and electronic data capture (EDC) systems.
• Familiarity with electronic medical records (EMR) and billing systems.
• Demonstrated leadership and team management abilities.
• Effective communication skills, both written and verbal.
• Detail-oriented with strong problem-solving skills.
• Ability to prioritize tasks and work under pressure.
• Ability to apply critical thinking and creative critical thinking skills across a wide variety of clinical studies.
• 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.