Columbia University Irving Medical Center · 4 months ago
Clinical Research Manager I - Cardiology
New York, NY
Full-time
Onsite
Mid Level
$70K/yr - $84K/yr
4+ years expColumbia University Irving Medical Center is seeking a Clinical Research Manager I for their Cardiology department. The role involves overseeing and coordinating clinical research studies and trials, ensuring compliance with regulatory guidelines, and supervising a team of Clinical Research Coordinators.
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Responsibilities
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
The CRM I may encounter various challenges and problems within their team or projects and should be able to find practical solutions. 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
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
Clinical Research Managers 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
Participate in business and management learning opportunities
Stay updated with industry trends, management techniques, and best practices to enhance your 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 will showcase your potential as a capable manager to prospective employers or superiors within your organization
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
Utilize analytical skills to solve simple managerial problems based on guidelines, protocols, and procedures
Conduct tasks with direct supervision from Director
Explain complex information; collaborate with others to build consensus. May present at conferences and seminars
Provide written and verbal communication, as well as perform active listening
Qualification
Required
Bachelor's degree or equivalent in education and/or experience, plus 4 years of experience
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 Medical Surveillance Required: Contact with patients and/or human research studies
Must successfully complete applicable compliance and systems training requirements
Preferred
Master's degree preferred
Company
Columbia University Irving Medical Center
Columbia University Irving Medical Center is a clinical and educational enterprise that offers medical, dental, and nursing services. It is a sub-organization of Columbia University.
10001+ employees
H1B Sponsorship
Columbia University Irving Medical Center has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
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Funding
Current Stage
Late StageLeadership Team
D
Donna Lynne
Senior Vice President and COO
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