Clinical Site Manager

Company: Aerotek
Location: Austin
Posted on: April 9, 2021

Job Description:

100% REMOTE CLINICAL SITE MANAGEMENT POSITIONDescription:

• Manages all clinical operational and quality aspects of allocated studies in compliance with ICH GCP.
• Develops Clinical tools e.g. Monitoring Plan, Monitoring Guidelines in conjunction with Data Quality Plan.
• Responsible for timely set up, organization, content and quality of the relevant sections of the Trial Master File
• May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, etc.
• In conjunction with the project manager prepares, organizes and presents at Investigator Meetings.
• Responsible for the implementation and training of standardized clinical monitoring processes according to corporate standard policies.
• Responsible for the timely archiving of documents and study materials for the clinical department.
• Monitors clinical activity timelines and metrics.
• Provides regular status updates to PM for client reports.
• Ensures regular project review, using Company tracking & management tools, implementing appropriate recovery actions to ensure project timelines are met.
• Reviews monitoring visit reports and ensures finalization is within contractual timeline.
• Manages CRF collection and query resolution process
• Monitors /co-monitors clinical trials as needed to assess performance and/or ensure contractual obligations are met.
• Leads regular conference call meetings with monitors and other clinical team members.
• May participate in bid defense meetings.Additional Skills & Qualifications:
  • Bachelor's degree or licensed certified health care training
  • Significant clinical research experience (comparable to 3 years) in all phases of study life cycle, including start up, interim and close out
  • Previous experience as a field CRA (preferred)
  • CRO/Pharma experience (preferred)Additional Benefits:
    • 100% Remote (must work EST)
    • 401K, Medical Benefits, Dental Benefits, Vision Benefits, HSA Account, etc. About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Austin , Clinical Site Manager, Executive , Austin, Texas