The Clinical Trial Associate (CTA) is responsible for providing administrative support for one or more clinical trial programs. This position will work closely with cross-functional teams to ensure that clinical trials are conducted in accordance with Standard Operating Procedures and applicable regulations governing the conduct of clinical trials.
Responsibilities:
- Perform general administrative tasks to support team members with clinical trial execution, e.g., assist with the development and formatting of documents, review and reconciliation of study-specific information, etc.
- Collect, disseminate, and/or track regulatory documents, as required
- Assist with filing documents in the Trial Master File
- Track and prepare study-specific information utilizing databases, spreadsheets, and other tools
- Manage and track study-specific contracts and clinical study payments in applicable systems
- Create and track purchase orders for clinical trial programs
- Manage and track clinical and non-clinical supplies, including purchase and shipping
- Assist with the development and distribution of site binders
- Set-up and coordinate meetings, take and distribute meeting minutes
- Participate in special projects, as assigned
- Authorize investigational product release
- Assist in the preparation of Investigator and Study Coordinator Meetings
- Communication for defined tasks and tracking of information between the study team and specified vendors
- Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs
Requirements / Qualifications:
- Bachelor degree or equivalent curriculum (scientific or healthcare discipline preferred). Persons without a formal degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration
- Requires no previous clinical trial coordination and/or site management experience
- Must be able to prioritize and manage a large volume of work and show attention to detail
- Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs
- Must be able to write clearly and summarize information effectively
- Must have the ability to build and maintain positive relationships with management and peers
- Experience using computer applications including spreadsheets, email, word-processing software and web-based systems