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Senior Clinical Research Coordinator

1 month ago


Detroit, United States Columbia University Full time

Position Summary

Women’s Genetics Division in the Department of Obstetrics and Gynecology is seeking a Women’s Genetics Senior Clinical Research Coordinator support the Director of Women’s Genetics and the Associate Director of Women’s Genetics Research in executing various research projects within the division. The individual will monitor and support all administrative items of the research portfolio relating to the Director and the Associate Director, support the NICHD-sponsored Prenatal Sequencing Repository, and support the IRBs of the Global Network. The individual will also support research data entry, consent to genetics research studies, and provide back up support to the Women’s Genetics Center Genetic Testing Coordinator and genetic counselors.

Responsibilities

Clinical Research Initiation and Coordination (30%)

Implement the study start up and site initiation visit (SVI) Recruit and enroll for genetics studies as assigned following all regulatory procedures Coordinate samples for all genetics studies as assigned Input data for all genetics studies and clinical genetics databases as assigned

Regulatory Management: (40%)

Coordinate and manage regulatory procedures for human subject research (e.g., IRB protocol, consent forms, interview data) for assigned protocols (genetics and global network). Responsible for preparation of documents for new projects, renewals, modifications, yearly submissions, correspondence, and audits related to IRB for multiple ongoing NIH-sponsored research studies, other genetics projects, Women’s Genetics Center protocols, and the Global Network Assist in the preparation of annual reports including regulatory information to funding and regulatory agencies. Ensure that regulatory compliance is met and that regulatory files are audit-ready

Administrative Management: (30%)

Assist with writing reports and manuscripts detailing research findings, program updates and others as applicable. Conduct relevant literature reviews as needed for grant submissions and publications Supplies: ensure that all supplies are ordered and shipped as needed.  Manage patient compensation through paycard, Trucentive, or other mechanisms as needed Organize and maintain manifests for all samples in genetics biobank Manage and execute successful grant submissions under the direction of the Associate Director; identify funding sources, plan deadlines, manage administration of applications Support Associate director and junior genetics faculty in abstracts and publications – set goals, deadlines, support submissions Manage MTAs/DUA’s for projects as applicable Perform other related duties and responsibilities as assigned/requested

Minimum Qualifications

Bachelor's degree or equivalent in education and experience, plus three years related experience Experience in clinical research Strong interpersonal and organizational skills Ability to exercise initiative and judgment Team player with ability to thrive in busy workplace environment Ability to think and write clearly and to edit materials accurately Ability to work under pressure and meet deadlines Ability to handle multiple projects simultaneously and prioritize tasks while maintaining responsibility for timely execution Working knowledge of Microsoft Office: Word, PowerPoint, and Excel Phlebotomy Certified (or other forms of certification in lieu of phlebotomy such as certified medical assistant, nursing degree, medical degree) - current or obtained within 6 months

Preferred Qualifications

Master’s or another advanced degree may substitute in part for experience Excellent interpersonal, written/oral communication, and organizational skills bullet Proficiency in Microsoft Office

The Department of Obstetrics and Gynecology is dedicated to the goal of building a multicultural faculty and staff committed to teaching, working and serving in a diverse community, and strongly encourages applications from candidates of traditionally underrepresented backgrounds.

We are continuously seeking to recruit individuals who will enhance the diversity of our workplace and the effectiveness of our organization.