Sr. CRA - Oncology (Temporary Role)
SRG is looking for a Sr. CRA within the oncology space to begin a contract ASAP. Responsibilities include but are not limited to:
- Manage specific study responsibilities as assigned by Sr. Manager or Clinical Operations Director/Sr. Director.
- Ensure Investigational Product (IP) needs for clinical studies are available and managed appropriately
- Assist with management of third party vendors
- Monitor and manage study sites, as necessary
- Track and prepare study- specific information utilizing databases, spreadsheet and other tools
- Assist in the development, assembly and distribution of study documents, manuals and tools
- Reporting of study issues to Sr. Manager or Clinical Operations Director/Sr. Director.
- Maintains and manages internal clinical trial files and documents
- Coordinates and plans for the availability of non-clinical supplies necessary to meet study requirements
- Other duties as assigned
- The candidate must have a BA/BS degree or equivalent; health science degree or biologic science degree is preferred.
- A minimum of 5 years experience in the pharmaceutical industry, with minimum 3 years direct experience in monitoring and managing study sites.
- The candidate should have significant experience with responsible roles in the conduct or management of Phase I – III clinical trials within Oncology.
- Must be sufficient at study start up and helping mentor younger CRAs through the study.
- The candidate must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S.; international regulations and guidelines, is preferred, but not required.
- Excellent oral and written communication, organizational and planning skills are required, ideally with the ability to manage budgets.
- The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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