The Global Health Department is looking for a Clinical Study Coordinator. The DRAMATIC study is a NIH funded multicenter, duration randomized, partially blinded, four-arm, phase II trial that will examine a five-drug regimen for multi-drug resistant tuberculosis. The clinical sites are in Philippines and Vietnam. Dr. Horsburgh is the Co-PI on the study and Dr. Wirtz is the Co-Investigator. This position involves working closely with the Co-Investigator and the clinical trial director and assisting in the job duties listed below.
Obtaining IP from the manufacturers (and the National TB Program, where indicated)
Overseeing shipping to the sites
Acquiring importation and regulatory clearance
Managing the trial drug supply chain,
Tracking drug expiry dates, quantities, stock outs, and lot numbers
Monitoring trial drug accountability for the DRAMATIC Clinical Trial.
Developing a Pharmacy Plan consisting of detailed instructions on trial drug handling for the site pharmacies and training of the site pharmacy staff.
Providing guidance to site pharmacists on issues related to the safe disposal of returned or expired trial drugs.
Preparing and implementing responses to any issues raised by study pharmacy monitoring reports.
Preparing any reports required by the pharmaceutical companies.
Preparing and updating the Manual of Procedures, protocol, Case Report Forms, and other study documents.
Preparing any reports required by the pharmaceutical companies, sponsor, FDA, and other agencies.
Maintaining the IRB application
Managing communication between all partners on the study, including sending out agendas, invites, and meeting minutes.
Master's Degree and Pharmaceutical degree
Work Experience 1-3 years
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are a VEVRAA Federal Contractor.
Internal Number: 2185
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