Clinical Research Coordinator

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week: 35
• Standard Work Schedule: In Person: M-F
• Building: Medical Center
• Salary Range: $65,000 - $70,000

Position Summary

The Clinical Research Coordinator will work under the guidance of the Clinical Research Manager to coordinate clinical research in the Department of Radiation Oncology. The Clinical Research Coordinator will be responsible for coordinating regulatory activities of human subjects/clinical research protocols. The Clinical Research Coordinator will also be responsible for patient screening, recruitment, data entry, and maintenance of study files and databases. Candidates must be bilingual (English and Spanish) to communicate with a large Hispanic patient population.

Responsibilities

REGULATORY REQUIREMENTS

• Coordinates the start-up and management of clinical research including IRB submissions and preparing/maintaining protocol-specific regulatory documents for study initiation, implementation, ongoing monitoring, and study closure.
• Prepares, tracks, and submits all correspondence and regulatory documentation required by the IRB and other regulatory bodies.
• Interacts with regulatory office and prioritizes study compliance and maintains study regulatory documentation and files.
• Performs internal audits and quality assurance checks on regulatory documentation.
• Works with PIs to develop informed consent forms.
• Leads the study phases from start up to accrual including preparing and submitting all regulatory documents for new study applications.
• Ensures regulatory approvals for all required components of human subjects clinical research are obtained and maintained according: annual IRB renewal submission, ancillary review communication annual reports, FDA annual reports, timely submission of all required documents.
• Provides updates on regulatory statuses and approvals.
• Ensures regulatory files are audit ready.
• Coordinates study monitoring and auditing visits. Prepares regulatory updates for monitoring visits.
• Independently and proactively tracks and resolves all concerns related to regulatory coordination.
• Responsible for ongoing study maintenance and tracking. Prepares and submits modifications and amendments.
• Ensures compliance with all regulatory, institutional and departmental requirements.
• Conducts and completes regulatory activities related to study closure.
• Assists with submissions related to serious adverse events (SAEs), unanticipated problems (UPs), and safety documentation and reports according to safety guidelines.
• Reports non-compliance and unanticipated problems as applicable.
• Stays up to date on and informs PIs and staff of regulatory changes.
• Serves as the department's regulatory point of contact for PIs, sponsors, and study teams throughout the medical center, cancer center, and other clinical departments.
• Develops and implements policies and procedures related to clinical research regulatory activities.
• Maintains quality assurance and control, including adherence to regulatory requirements.

RESEARCH COORDINATION

• Reviews and supports PIs in the development of study protocols. Coordinates protocol submissions to the Clinical Trials Office, Protocol Review and Monitoring Committee, Data and Safety Monitoring Committee, Fiscal Support Committee, and Institutional Review Board.
• Assists with study start up and submission to appropriate offices.
• Attend and transcribe focus group interviews and meetings.
• Administration and collection of questionnaires and photographs.
• Maintain research study supply inventory.
• Under the supervision of the Clinical Research Manager, maintains procedures for timely and complete Clinical Research Coordinator activities. Complies with supervision tools such as work logs and regular meetings.

PATIENT COORDINATION

• Responsible for day-to-day screening and recruitment of subjects, including active interaction with potential participants in high-volume patient waiting rooms, via telephone, and written communication. Maintains screening and recruitment logs.
• Obtains in-person informed consent; assesses and reports barriers to recruitment.
• Responsible for biospecimen collection (i.e., blood, saliva, and urine), tracking, transporting, and shipping.
• Coordinates study enrollment, protocol treatment, and follow-up care for patients participating in clinical research.
• Communicates with various departments, physicians, and research teams to ensure accuracy and timely retrieval of data.

DATA COORDINATION

• Reviews and follows research protocols and determines data management requirements. Responsible for data entry requirements for each patient enrolled. Maintains study files and databases.
• Abstracts, assembles, and organizes clinical research data.

OTHER

• Prepares for and contributes to meetings with PIs, sponsors, and study teams throughout the medical center, cancer center, and other clinical departments.
• Performs additional duties & responsibilities related to research as assigned/requested.

Minimum Qualifications

• Bachelor's degree in nursing, biological science, public health, or business/administration degree such as finance, accounting, business administration, public administration, or a directly related field.
• A minimum of 1.5 years of relevant research experience.
• Bilingual.
• Ability to communicate in Spanish with a large Hispanic patient population.

Other Requirements

• Demonstrated ability to write informed consent form documents.
• Experience with central and local IRB submissions.
• Ability to interpret and apply regulatory requirements.
• Experience with research data entry.
• Strong organizational, time management, and attention to detail skills.
• Ability to communicate effectively both in verbal and written formats.
• Ability to work both independently and collaboratively within an integrated team.
• Strong analytical and problem-solving skills.
• Demonstrated empathy, discretion, and follow-through.
• Proficiency in Microsoft Office (Word, Excel, and PowerPoint) or similar software and an ability and willingness to learn new systems and programs.

Equal Opportunity Employer / Disability / Veteran

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