Description
Duties:Accountable for the day-to-day operational oversight of 1-4 clinical trials including trail start-up, conduct, and close-out activities
Mentoring and support of junior Clinical Operations staff
Facilitates SMT Meeting, responsible for the timely setting of agendas, effective conduct of SMT meetings and timely issuance of meeting minutes
Facilitates in all operational activities pertaining to the execution of clinical trials
Maintains regular internal contact with relevant departments such as Regulatory Affairs, Drug Safety and others as necessary
Attending meetings for project kick-off with the CROs
Visits the CROs to interact with their functional teams and review the study files.
Assists in the selection and initiation of sites
Not an exhaustive list of duties and responsibilities
Requirements:
BS/BA degree in related discipline and 8 years of related experience
Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the US
Exhibits ability to learn and apply foreign regulations to the clinical trial/research process.
Performs job duties with minimal to no guidance from the Assoc. Director/Director, Clinical Operations
Oncology background required