The Clinical Research Coordinator I will be responsible for: Review of new protocols, consent documents and budgets for operational and fiscal feasibility. In collaboration with the Regulatory Manager, ensures start up regulatory documents are completed, signed as appropriate and provided to the sponsor. Participates in pre-study, initiation, monitoring and close out visits. In collaboration with the Clinical Manager, organizes roll out and training of new studies within interdisciplinary teams. Communicates protocol amendments to appropriate parties and ensures training is complete as required. Establishes internal and external relationships with local physicians and clinical teams. Prepares recruitment plans and revise as necessary to meet target enrollment goals.
Screens for eligibility by reviewing medical record source documents, inclusion/exclusion criteria, and subjects' willingness and capability to follow required clinical research procedures, processes, and follow up appointments.
Obtains informed consent and/or oversee informed consent process from research subjects prior to any study-related procedures.
Ensures all aspects of the research study are carried out in accordance with the IRB approved protocol, institutional policy, FDA regulations and GCP guidelines. Ensures follow up visits are scheduled within window and all necessary study related procedures are conducted according to the protocol.
Oversees maintenance of the screening/enrollment log and study manager.
Ensures appropriate reporting and documentation of protocol deviations and exemptions as well as development and implementation of corrective action plans for review by the Clinical Manager and Administrative Director as needed.
In collaboration with the Regulatory Manager, ensures RASCAL attached documents are correct and current, that outdated documents are archived and that all applicable staff have access to most recent recruitment materials, including the informed consent document in Spanish and English.
In collaboration with the Regulatory Manager, ensures protocol events (modifications, renewal, unanticipated problems, terminations) are submitted to the IRB and approval documentation is in place.
Ensures appropriate data is abstracted from medical records, clinic, consultation, and referral notes to study forms and recorded accurately onto case report forms; ensure appropriate maintenance of source documentation for all case report entries.
Ensures all data queries are resolved.
Meet regularly with investigator and research team to discuss subject participation and study progress.
Communicates all protocol-related issues to appropriate study personnel or manager.
Attends study specific on site meetings, Investigator meetings, conference calls and monthly CRC meetings as required or asked to do so.
Apprises principal investigator, of all study specific medical issues for guidance.
Apprises Research Director and Clinical Manager of all study specific operations and/or compliance issues.
Reviews and responds to any data queries or monitoring and auditing findings and escalates issues to Clinical Manager as necessary.
Assures the maintenance of accurate and complete records including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, device utilization logs, subject logs and study-related communications.
Tracks and reports as applicable adverse events, serious adverse events, protocol waivers, deviations, and violations.
Other duties as assigned.
Requires a bachelor's degree or equivalent in education, training and experience, plus three years of related experience.
Fluency in Spanish
Participation in Medical Surveillance Program.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 502287
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.