Advertised Summary Job Description: The Clinical Research Coordinator will report to the Principal Investigator (PI) and the Clinical Research Manager (CRM) within the Department of Medicine, Division of Rheumatology. The candidate will support multiple research studies (government, private and pharmaceutical) through the coordination and implementation of clinical trials and protocols involving human subjects. The candidate will identify, recruit, and consent eligible participants; conduct visits as outlined in study protocols and in accordance with Good Clinical practices (GCP) and HIPAA guidelines. The incumbent will perform screening, counseling and recruitment of study subjects or identify potential patients for studies in research protocols. The coordinator will perform research-related services, such as coordinating study visits, scheduling study visits, telephone calls, data collection, data entry and transmission, specimen collection, processing and storing or shipment of specimens. The CRC I will be responsible for collecting, transporting, processing and shipping blood samples in accordance with federal, state and institutional policies, as well as delineated in sponsor's protocol. The CRC will also assist with preparation of data for statistician and will help develop ongoing reports for the PI and CRM.
Additionally, the candidate will consult with medical records of outlying clinics and hospitals to obtain pertinent data and patient information. The CRC I will interface with various hospital departments such as medical records, the CTSA, radiology, the IRB/HRPO and others as needed. Coordinate the collection of all research data points as assigned, whether through research visits, chart abstraction or telephone.
The candidate will collect data and complete case report forms for all study visits as required by the protocol and consistent with GCP, HIPAA, FDA/HHS, state and institutional regulations. The CRC I candidate will ensure regulatory documents and administrative files for each protocol are up to date. Patient research records will be created and maintained by the CRC I. The incumbent will also be required to enter research data into a database program and other study specific electronic databases. Attend and participate in Investigator, site initiation and monitoring meetings as assigned. Perform additional responsibilities as needed.
General Minimum Qualifications: Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.
Additional Specific Minimum Qualifications: Must be familiar with data collection and analysis and possess the ability to take initiative and work independently. Incumbent must be self-directed and able to make independent decisions within the parameters of all federal, state, institutional and departmental guidelines. Experience in Clinical Research and Patient Care Setting. Must have excellent interpersonal skills, written, verbal and organizational skills. Proficiency in Microsoft office. Complete proficiency in written and spoken English. Must be able to work effectively with minimal supervision. Must complete Good Clinical Practices (GCP) and HIPAA certification upon hire.
Preferred Qualifications: Experience in the administration of clinical trials. Fluency in Spanish. Experience with patient contact and/or research subjects. Pharmaceutical clinical trial experience a plus.
As a member of the National Collegiate Athletic Association (NCAA) and the Council of Ivy Group Presidents (Ivy League), it is imperative that members of the Columbia University community, in all matters related to the intercollegiate athletics program, exhibit the highest professional standards and ethical behavior with regard to adherence to NCAA, Conference, University, and Department of Intercollegiate Athletics and Physical Education rules and regulations.
Columbia University is an Equal Opportunity/Affirmative Action employer.
Internal Number: 126_173532
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.