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.
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
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
Handling data management requirements for each patient enrolled
Abstracts, assembles, and organizes clinical research data
Coordinator performs other related duties and participates in special projects as assigned
Bachelor's Degree or equivalent in education, training and experience, plus 2 years of related experience
Experience in a clinical research setting with knowledge of HIPAA and GCP
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.
Internal Number: 499813
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.