Description
Responsibilities:- Responsible for the implementation of clinical trial activities as defined by the Study Management Team. Works closely with investigative site personnel, CROs, and other study vendors under the direction of a Sr. CRA or CPM.
- Works with Medical Monitor and CPM or Study Lead to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies.
- May act as the lead for a region in a global trial or as part of a regional team.
- Performs the activities associated with the implementation and monitoring of clinical trials such as assisting with the development of study plans, study tools, and training materials.
- Assists in 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.
- Oversees drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies.
- Assists with preparation and maintenance of study drug forecast, as needed.
- Maintains study timelines. Identifies and communicates trial issues that will impact budget, resources and/or timelines.
- Participate in site monitoring and/or co-monitoring activities, as needed.
- Experience reviewing monitoring reports and monitoring visit letters is required.
- Reviews and critiques electronic CRFs for accuracy and completeness. Oversees data discrepancy management and training as needed.
- Assists with training for internal and external CRAs, CRO team members, and investigative site staff.
- Ensures that supportive study documents are completed (e.g., IXRS specification documents, specific IXRS scripts, non-clinical supply materials).
- Able to independently prioritize tasks on a day to day basis.
- Able to complete tasks with minimal supervision; able to escalate to manager if goals are in danger of being unmet.
- Contributes to wider organizational goals and/or activities as assigned.
Requirements:
- 4 years industry experience in drug development, including prior site monitoring experience.
- Oncology experience preferred but not required.
- Previous on-site monitoring experience is preferred.
- Global trial and CRO management experience is preferred.
- PC literacy: 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.
Education:
- BS/BA in Life Science or related discipline.