The Clinical Trial Assistant (CTA) works as part of the Study Management Team to contribute towards the successful management and execution of clinical trials.
ESSENTIAL DUTIES & RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
- Provide general administrative support to the Clinical Operations Department.
- Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.
- Support the Clinical Operations teams with ongoing conduct of studies.
- Assist project teams with study specific documentation and guidelines as appropriate.
- Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
- Assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
- Coordinate ordering/dispatch and tracking of study materials.
- Assist project teams with trial progress tracking.
- Assist in coordination of Vendor payments, tracking of payments and accruals, if applicable.
- Assist Clinical Trial Managers with specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
- Assist in the tracking and distribution of safety reports.
- Attend study team meetings and generate agendas and meeting minutes.
- Assist the Clinical Trial Managers and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
- Bachelor’s Degree preferred
- Minimum of two (2) years in clinical research or healthcare related industry, or equivalent combination of education and experience; site monitoring experience a plus
- Experience in scientific discipline and multiple therapeutic areas preferred
- Experience/training in the following areas: GxP Regulations, ICH Guidelines, Good Quality Practices, 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development and Approval Process
- Proficiency in MS Office including Word, Excel, and PowerPoint
- Ability to work in a team or independently as required
- Effective written and verbal communication skills
- Critically evaluates job tasks and the impact on overall trial management objectives
- Sound problem-solving capabilities
- Good judgment in triaging issues from internal and external customers
- Effectively collaborates with Clinical Trial Team members
- Outstanding organizational skills with the ability to multi-task and prioritize
- Exceptional attention to detail
- Available for minimal travel (<15%) including overnight stays, when required.
- Ability to drive and have a valid driver’s license.
The above description is intended to describe the general nature of the job and may include other duties as assumed or assigned; it is not intended to be all inclusive or limit the duties of the position