Description
Responsibilities:- Facilitates weekly SMT meetings , including setting and circulating agendas, seeking team inputs on upcoming agenda items, taking meeting minutes/notes, drafting and circulating meeting minutes/notes, and identifying/logging/ensuring resolution of issues
- Maintains regular internal contact with relevant departments such as Clinical Development, Clinical Science, Clinical Supplies, Regulatory Affairs, Drug Safety and others as necessary
- Responsible for the day-to-day interaction with multiple CROs in the execution of ongoing clinical trials
- Regularly assists in the creation and review of study protocols, informed consents, case report forms, clinical study reports, study materials and monitoring tools
- May participate in reviews and resolution of discrepancies in clinical data with responsible CROs and clinical sites
- In conjunction with CRO monitors, mayconduct study initiation, routine site visits, and close-out visits
- Travel may be required in the United States up to 20% in support of CRO activities
Requirements:
- BS/BA/RN degree in related discipline and three years of related experience
- At least three years experience as a Clinical Research Associate (or a combination of one year experience as a Clinical Research Associate and two years in a comparable role) with increasing responsibilities in study management are preferred
- Knowledgeable in Good Clinical Practice requirements and their application to the conduct of clinical studies in the United States
- Experience in management of multiple sites as a Clinical Research Associate is preferred
To find out more about Real please visit www.realstaffing.com