• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $64,350 - $65,250 Annual

Position Summary

The Clinical Research Coordinator provides research coordination support for multiple clinical research projects.  The primary focus of this role is to assist with the coordination of studies rather than independently managing clinical trials.  The position involves coordinating various clinical research projects, such as registries, retrospective data reviews, long-term follow-up studies, and other non-interventional studies.

Responsibilities

Clinical Research Responsibilities:

• Screen participants for study eligibility and accurately enroll them in various databases.
• Perform simple study procedures with accuracy.
• Understand the structure of study protocols and interpret study requirements to ensure compliance.
• Follow proper documentation techniques as outlined in the ICH-GCP guidelines.
• Process subject reimbursement using pcards.
• Retrieve and utilize information from electronic medical records (EMR) and databases/CTMS/EDC.
• Maintain essential regulatory documents as required.
• Assist the research coordinator in the conduct of Site Initiation Visits (SIV) and attend monitor visits and audits.

Data Coordination Responsibilities:

• Collect basic demographic information during study visits.
• Enter data into forms (CRFs) on paper, databases, or electronic data capture systems (EDCs).
• Assist in collecting external medical records and radiology CDs as assigned.
• Administer minimal risk consents independently or complex consents under supervision.
• Conduct surveys and questionnaires.
• Verify the accuracy of own work and resolve simple queries.
• Perform concomitant medications abstraction.
• Build patient research study charts.
• Assist in quality control efforts, such as reviewing consents for signatures.

Regulatory Coordination Responsibilities:

• Collaborate with regulatory support to collect essential documents and maintain the regulatory binder (e.g., CVs, MD licenses, lab certifications, IRB rosters, lab norms).
• Assist with adverse events (AEs) and serious adverse events (SAEs).
• Follow proper documentation techniques as outlined in the ICH-GCP guidelines.

Administrative Responsibilities:

• Demonstrate an understanding of the clinical research objectives associated with the program.
• Communicate with study participants by sending study correspondence via mail or email.
• Schedule subjects for research visits and follow-up appointments.
• Monitor study calendar for completion of study procedures.
• Manage study supply inventory.
• Utilize documents and systems to track recruitment and retention of participants.
• Work with regulatory support to maintain the regulatory binder.

Training:

• Gain appropriate training and knowledge of electronic medical records (EMR), clinical trial management systems (CTMS), electronic data capture (EDC), databases, and other relevant systems.
• Willingly learn and utilize available technology and systems to fulfill job requirements.
• Understand the disease process associated with the program.
• Attend and actively participate in all assigned training classes.

Perform other responsibilities as assigned.

**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 in Health Science or equivalent in education, training and experience.

Preferred Qualifications

• At least two years of related experience.
• Knowledge of university policies and procedures.
• Previous experience working in a large and complex healthcare setting Type preferred qualifications

Other Requirements

• Familiarity with medical terminology.
• Ability to communicate effectively with staff and faculty members at all levels.     
• 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.