Clinical Site Manager
Posted on: April 9, 2021
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
- 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 &
- Bachelor's degree or licensed certified health care
- 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, Raleigh , Clinical Site Manager, Executive , Raleigh, North Carolina
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