Description
The candidate, working closely with his/her Clinical Project Manager, will have overall responsibilities for managing the full scope of clinical trials (protocol development to final report, regulatory filing and/or publications) and coordinating cross functional efforts in order to achieve study objectives and corporate goals.Responsibilities:
- Assists with managing defined aspects of clinical trials to ensure trials are completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Perform the activities associated with the implementation and monitoring of clinical trials.
- May participate in site monitoring and/or co-monitoring activities, as needed.
- Experience creating and/or reviewing monitoring reports and monitoring visit letters is required.
- Reviews and critiques electronic CRFs for accuracy and completeness. Oversees data discrepancy management and retraining as needed.
- Provides or assists with training internal and external CRAs, CRO team members, and investigative site staff.
- Ensures that supportive study documents are completed (e.g., scopes of work, work orders, IXRS specification documents, specific IXRS scripts, non-clinical supply materials).
- Review and track study Trial Master Files (TMF) and submit documents to central records for storage.
- Perform on-going review of the TMF to ensure files are properly maintained and up to date, archived and stored.
- Maintain and enter clinical study details into Clinical Trial Management System (CTMS).
- Responsibility for creating and maintaining documents, tables, databases, spreadsheets and files as needed.
- Attend meetings, take and distribute meeting minutes.
Requirements:
- Proficiency with word processing, spreadsheet, database, and presentation software (MSOffice skills such as Outlook, Word, Excel, PowerPoint) and with filing systems.
- Computer skills should be relevant to job roles and tasks required.
- Global trial and CRO management experience is preferred.
- 2-5 years industry experience in drug development, including prior on-site monitoring experience.
- Phase II/III Oncology experience preferred but not required.
- Applicants must be based in the SF Bay Area; this is an on-site position
Education:
BS/BA in Life Science or related discipline.