Clinical Research Coordinator

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 Coordinator manages clinical trials conducted through the Clinical Protocol & Data Management Office. This position reports directly to the Clinical Research Manager of the specific disease site this incumbent is assigned to. The Clinical Research Coordinator manages clinical trials (including some regulatory and budget requirements) and assists in the coordination of tests / visits for patients, working with the study team to maximize work efficiency to gather all required data and relevant clinical information.

Subject to business needs, we may support flexible and hybrid work arrangements. Options will be discussed during the interview process.

Responsibilities

Responsibilities include, but are not limited to :

GENERAL STUDY MANAGEMENT

• Reviewing research protocols
• Assisting Principal Investigators in drafting budgets and submitting studies
• Interacting with the regulatory office to maintain regulatory documentation and administrative files for each protocol
• Under the supervision of the clinical research management office supervisor, the coordinator maintains procedures necessary for timely and complete data management and complies with required supervision tools such as work logs and regular meetings.
• The coordinator will also comply with necessary regulatory responsibilities

PATIENT MANAGEMENT

• Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical trials in conjunction with the clinical research nurse, research pharmacy, treatment center, and other study staff
• Working with the research nurse, treating physicians, and Principal Investigators to confirm that each patient meets eligibility criteria specified for protocols and enrollment into clinical trials
• Communicating with various departments, physicians, labs, outside hospitals, and all members of the clinical team to ensure accuracy, timely retrieval of data, and confirm the appropriateness and timeliness of tests
• Collecting follow-up data on patient post-treatment as required by the protocol and submit monthly reports to the clinical protocol office, tracking patient enrollment and accounts / payments for sponsored protocols
• Completes timely research billing review
• Maintains and updates sponsor-related, university and department databases / logs

DATA MANAGEMENT

• Handling data management requirements for each patient enrolled
• Abstracts, assembles, and organizes clinical research data

OTHER

• Coordinator performs other related duties and participates in special projects as assigned

Minimum Qualifications

• Bachelor's Degree or equivalent in education, training, and experience.

Preferred Qualifications

• Experience in clinical research setting with knowledge of HIPAA and GCP.

Other Requirements

Excellent interpersonal and organizational skills.

Computer Skills : proficiency with MS Word programs and familiarity with Mac and PC platforms.

Equal Opportunity Employer / Disability / Veteran

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