Clinical Research Manager 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 Manager I (CRM I) is a professional who oversees and coordinates the execution of clinical research studies and trials. These trials are conducted to evaluate the safety, efficacy, and effectiveness of new medical treatments, drugs, devices, or interventions. The CRM I plays a vital role in ensuring that clinical trials are conducted ethically, safely, and in compliance with regulatory guidelines. This CRM I supervises Clinical Research Coordinators and ensures accountability to Cardiology Research guidance documents and standard operating procedures. The CRM I applies critical thinking and creative critical thinking skills across a wide variety of clinical studies. The CRM I develops processes, procedures, tools, and training to enhance clinical research activities. May conduct quality assurance audits and is able to identify noncompliance concerns, assess cause, create corrective action plans, and implement independently under supervision from the Director.

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 their 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 to challenges and problems within the 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 to 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 RC 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. 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.

Learning and Development :

• Participate in business and management learning opportunities.
• 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 to accelerate your growth as a future manager.
• Demonstrate an initiative-taking attitude and a willingness to learn.

Competency :

Functional Knowledge :

• Study Management-Master competency of the specific responsibilities and duties from the CRC III. Strong understanding of Office of Human Subjects Protections (45CRF46.116 and 46.117), the Food and Drug Administration (21 CFR 50.20), Health Insurance Portability and Accountability Act of 1996 (HIPAA), Good Clinical Practice, and institutional policies and procedure.
• Team Management-Foundational understanding of CUIMC's Human Resources and organizational policies and procedure.

Problem Solving :

• Study Management-Solve a broad range of complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information and education and / or equivalent experience.
• Team Management-Utilize analytical skills to solve simple managerial problems based on guidelines, protocols, and procedures.

Decision Making / Autonomy

• Study Management-Solve a broad range of complex problems; take a new perspective on existing solutions; exercise judgment based on the analysis of multiple sources of information and education and / or equivalent experience.
• Team management-Conduct tasks with direct supervision from Director.

Communication Skills

• Study Management-Explain complex information; collaborate with others to build consensus. May present at conferences and seminars.
• Team management-Adept at written and verbal communication, as well as active listening.

Perform other responsibilities as needed.

The responsibilities outlined above may vary depending on the specific needs of the research unit.

Minimum Qualifications

• Bachelor's degree or equivalent in education and / or experience, plus 4 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.

Participation in Medial Surveillance Required :

• Contact with patients and / or human research studies.
• Must successfully complete applicable compliance and systems training requirements.

Equal Opportunity Employer / Disability / Veteran

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