Clinical Research Manager

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: Mon - Fri (9am - 5pm)
• Building:
• Salary Range: 69,300.00 - 88,400.00

Position Summary

The Clinical Research Manager in the Department of Surgery will work collaboratively in support of the research financial and clinical trial operations of the Department of Surgery.

Responsibilities

Research Financial Management:

• Support and monitor research-related financial activities to assure compliance with University, P&S, and funding agency regulations; prepare and submit required reports.
• Provide administrative direction for all grant management activities.
• Manage the pre-award, post-award and close-out process of all sponsored projects, function as a resource for principal investigators.
• Monitor and analyze grant budgets and notify principal investigators of the need to reallocate projected expenses; ensure any overdrafts are properly corrected.
• Coordinate day-to-day activities related to grants and contracts and ensure compliance with internal and external policies and procedures.
• Assist with post-award financial management for all grants and contracts, including reconciling analyzing specific activity on sponsored projects.
• Monitor and process post-award financial transactions.
• Process monthly allocations and project reviews and close-out.

Clinical Trials Management:

• Present regular updates to the Principal Investigators and co-/sub-Investigators for the trials in the assigned therapeutic areas, including enrollment goals and progress, concerns or ideas for development, and upcoming opportunities.
• Improve and develop plans for subject recruitment, protocol implementation, identify necessary resources and request as appropriate.
• Train staff for onboarding and ongoing learning.
• Assist the Director in the preparation of study budgets, research related cost estimate forms, start-up activities, and initiation of all new adult research studies and trials.
• Provide direct supervision of research coordinators, assistants, and technicians to ensure compliance with federal, institutional, and departmental guidelines or policies.
• Obtain and maintain regulatory approvals, documents, and training for trials in collaboration with the regulatory team.
• Support screening patients, consenting, enrolling, and general conduct research visits for clinical trials and research.
• Contribute to development and enforcement of policies, procedures, and practices in accordance with regulatory, departmental, institutional, and federal guidelines.
• Ensure complete and compliant filing of study documents and case report forms.
• Clearly and effectively communicate with potential study subjects, clinicians, other health care providers, ancillary staff, sponsors, other institutional offices, and research office staff.
• Assist in other research related activities and projects as needed.

Other special projects:

• Ad-hoc projects to provide support for the research mission.
• Other tasks as required.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience, plus four years of related experience.

Preferred Qualifications

• Must have strong organizational skills and be capable of working independently as well as collaboratively.
• Must be detail oriented and be able to handle competing priorities.
• Proficiency with technology and social media platforms.

Other Requirements

• Working collaboratively with a diverse group of faculty and senior administrators.
• Analyzing complex issues.
• Financial management.
• Operational expertise in academic science departments or similar organizational units.
• Excellent oral and written communication.
• Ability to identify opportunities to increase operational efficiencies and quality of service.
• Proficient in Spanish.
• Intermediate to advanced level MS Office skills, PeopleSoft, Adobe, EPIC.
• Strong analytical ability including experience in cost/benefit analysis, financial applications and accounting systems required.
• Effective interpersonal and communication skills required.

Equal Opportunity Employer / Disability / Veteran

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