Job Summary: This position will be the Project Manager for a large multi-site clinical trial where the Clinical Site is also the Coordination Center for the clinical trial. Coordinate all aspects of the clinical trial at the Sponsor Level including but not limited to:
Procuring study drug Site selection and management Vendor selection Consent form development Study document creation Study and data monitoring oversight SAE and protocol deviation reporting and management Communication and periodic reporting to regulatory agencies and financial sponsors Secure and track all regulatory and financial documents from all sites This is a critical role in maintaining separation as Site and Coordination Center. The candidate must have the ability and desire to:
Schedule meetings Write and review documents Design CRFs Answer site questions Identify and work with vendors (drug supply, labs, central pharmacy) Work with IRBs Consult with biostatisticians Develop study manuals for sites and the Coordination Center Develop SAE workflow and protocol violation workflow Track study metrics Prepare Investigators Meeting and necessary trainings Develop enrollment plan Prepare reports to DSMB and set up DSMB meetings Review site monitoring reports Conduct study team meetings Schedule and attend Steering Committee Meetings Develop SOPs The candidate must communicate well with PIs, Data Monitors, Data Managers, Monitors including DSMB, vendors, and sites (Nurse, CRA, PI, etc.), as well as regulatory and funding agencies. The candidate must be organized, have the ability to see the big picture as well as small details, be good at time management, team-oriented, patient, flexible, creative, and have the ability to anticipate potential problems and suggest solutions. Candidates should be able to work well under pressure.
A candidate with a nursing degree would engage in the acquisition of blood and urine samples, which would be processed, stored, and catalogued for biomarker studies. Candidates with laboratory bench experience would engage in processing blood and urine samples that would be stored and catalogued for biomarker studies.
Minimum Qualifications: Bachelor's degree and two years of related experience or an equivalent combination of education and experience.
Preferred Qualifications: Master's Degree or Doctorate Degree
Work Days: Message to Applicants: Recruitment Office: Human Resources
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