BUSPH Center for Global Health & Development seeks Clinical Trial Director
Job Description
The Clinical Trial Director will oversee all managerial aspects of the clinical trial, the efficacy and safety of Levofloxacin for the treatment of Multi-Drug Resistant Tuberculosis (Opti-Q), under the direction of the Principal Investigator.
The selected candidate will be responsible for coordinating all aspects of the study, including monitoring progress at sites in Peru and South Africa, coordinating communication between PI and co-Investigators and all collaborating organizations engaged in the trial.
Clinical Trial Management:
-Assist sites with maintaining patient recruitment in keeping with study timeline
-Monitor completion of study milestones as specified in the study proposal
-Monitor and track the activities of the subcontract partners to ensure that all tasks are completed as specified in the milestones and in the contracts, and informing the PI when milestones are not met or are falling behind schedule
-Organize team and subcommittee meetings (both face to face and by conference call)
-Serve as point of contact for the NIH and CDC, coordinate regular communication
Regulatory Management:
-Manage the importing of drugs and supplies, following export/import regulations
-Identify regulatory issues and work with site staff to ensure these issues are resolved in a timely manner
-Ensure that sites have all necessary regulatory documents
-Oversee BU IRB submissions, and ensure local IRB approvals are secured and maintained
Information Systems & Reporting:
-Establish electronic trial master file
-Generate reports on study progress for Principal Investigator and co-Investigators
-Draft progress reports for NIH, ensure timely submission of all reporting requirements
Supervision and Training:
-Assure training of site personnel in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Pharmacy Practice
-Train the site staff on the protocol and amendments
-Train staff in and ensure adherence to specimen collection, labeling and shipping procedures
-Supervise activities of the Study Coordinator
Apply through BU Human Resources HERE.
