Study Initiation Coordinator | Columbia University - Military Veterans

at HERC - Metro New York & Southern Connecticut

New York, New York

Position Summary The Study Initiation Coordinator manages the EMR study build in addition to protocol initiation in the Clinical Protocol and Data Management Office. This position reports directly to a Clinical Research Program Manager. Responsibilities EMR STUDY MANAGEMENT Oversees and manages projects related to EMR protocol implementation. Completes and maintains EMR protocol builds in conjunction with the study team. Prioritizes and tracks disease team progress for all protocols in the portfolio. Creates tracking tools in order to keep all stakeholders apprised of protocol completion progress and implementation. PROTOCOL MANAGEMENT Assist in portfolio and pipeline development for all disease teams. Collect, review, organize, and assemble start-up submissions. Completes submission for amendments that require updated contract and budget negotiations. Collaborates with Clinical Research Managers and other team members to accomplish tasks and projects that are instrumental to study start up process. Completes and submits study start up documents to the Clinical Trials office and Sponsored Projects. Completes and tracks Cost Estimates related to study start up and amendments. Collaborates with the Clinical Trials Office, Research Pharmacy, Radiology, Sponsors and other interested parties to assist in an efficient and timely study initiation Organizes projects and collaborates with multidisciplinary team and other health care personnel as needed to complete assigned tasks. Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements. Attends regularly scheduled conferences and meetings. DEPARTMENT INITIATIVES Assist the CPDM Leadership Team in developing, implementing, and executing departmental Standard Operating Procedures (SOPs). Plan and manage Projects or sub-projects as assigned. Develop and maintain standardized forms, study tools, and provides education sessions for updated information. OTHER Performs other related duties as assigned. Minimum Qualifications Bachelor's degree or equivalent in education and experience plus 3 years of related experience. Preferred Qualifications Experience working with electronic medical records preferably EPIC. 2 years clinical trials experience including study initiation management with at least 1 year oncology clinical trials. Other Requirements Experience in implementing information systems, clinical initiatives, including electronic healthcare, academic and research systems Excellent communication and interpersonal skills with strong leadership and multitasking abilities. 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.

New York, New York

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