Careers

JOB DESCRIPTION:

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.

REQUIREMENTS:

• 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

TRAVEL REQUIRED

• Available for minimal travel (<15%) including overnight stays, when required.
• Ability to drive and have a valid driver’s license.

EOE

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