The Clinical Research Coordinator will review new protocols, consent documents and budgets for operational and fiscal feasibility.
In collaboration with the Regulatory Manager, ensure start up regulatory documents are completed, signed as appropriate and provided to the sponsor.
Participate in pre- study, initiation, monitoring and close out visits.
In collaboration with the Clinical Manager, organizes roll out and training of new studies withing interdisciplinary teams.
Communicates protocol amendments to appropriate parties and ensures training is completed as required.
Establish internal and external relationships with local physicians and clinical teams and prepare recruitment plans and revise as necessary to meet target enrollment goals.
The Clinical Research Coordinator will screen 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.
Obtain informed consent and/or oversee informed consent process from research subjects prior to any study-related procedures.
Ensure all aspects of the research study are carried out in accordance with the IRB approved protocol, intuitional policy, FDA regulations and GCP guidelines.
Ensure follow up visits are scheduled within window and all necessary study related procedures are conducted according to the protocol.
Oversee maintenance of the screening/enrollment log and study manager.
Ensure 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In collaboration with the Regulatory Manager, ensure RASCAL attached documents are correct and current, that outdated documents are archived and that all applicable staff have access to most recent recruitment materials, including the informed consent document in Spanish and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 and ensure protocol events (modifications, renewal, unanticipated problems, and terminations) are submitted to the IRV and approval documentation is in place.
Ensure 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 and all data queries are resolved.
Meet regularly with investigator and research team to discuss subject participation and study progress and communicate all protocol - related issues to appropriate study personnel or manager.
Attend specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings as required or asked to do so.
Apprise principal investigator of all study specific medical issues for guidance and apprises Research Director and Clinical Manager of all study specific operations and/or compliance issues.
Review and respond to any data queries or monitoring and auditing findings and escalates issues to Clinical Manager as necessary.
Assure 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.
Track and report as applicable adverse events, serious adverse events, protocol waivers, deviations, and violations.
Perform other duties as assigned.
Requires a bachelor's degree or equivalent in education, training and experience, plus two years of related experience.
Previous experience in clinical trials is required for this position.
Experience with IRB interactions, CRC, and Spanish speaking preferred.
Participation in Medical Surveillance Program.
Must successfully complete systems training requirements.
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 511981
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.