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
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