Clinical Trial Assistant

Job purpose

The Clinical Trial Assistant will provide administrative support to the Clinical team. Responsible for assisting with day-to-day operations of clinical studies. This position requires basic knowledge of clinical trials, excellent organizational skills and the ability to perform at high levels in a fast-paced, dynamic environment.

Duties and responsibilities

1. Assist team members with designated administrative tasks in support of clinical trial execution and management.
2. Perform study tracking to ensure that study files are current, accurate and complete with applicable local regulatory requirements and ICH/GCP guidelines.
3. Assist in generation of study start up materials and support feasibility study activities.
4. Participate in the design and implementation of case report forms (CRF) and completion guidelines, and database testing.
5. Maintain clinical study schedules; collaborate with study team on subject tracking to ensure protocol compliance.
6. Maintain and organize publication library, clinical study documents and reference materials.
7. Assist Clinical Research Associates (CRA) and management with resolution of issues 
8. Able to review data within the Electronic Data Capture (EDC) and file management systems, perform and collate data downloads, reports, and prepare summaries of data extractions for review.
9. Collaborate with CRAs, Data Management and vendors on data cleaning, tracking and data analysis quality.
10. Assist in the production of presentations, etc., as needed for project, departmental, and/or business development presentations.
11. Actively order and maintain ancillary clinical study supplies required for conduct of clinical trials.
12. Assist with preparation, shipping, handling, distribution, and/or accountability of clinical trial supplies.
13. Contribute to the development of clinical trial management best practice processes and Standard Operating Procedures (SOP).
14. Maintain up-to-date knowledge of current regulations and guidelines to ensure compliance.
15. Solve routine problems of limited scope and complexity following established policies and procedures.
16. Work collaboratively with team to solve more complex issues.
17. Other duties as assigned.

Skills

1. Proficient in Microsoft Office applications (Word, Excel, and PowerPoint), Adobe and video/web conferencing. Knowledge of relational databases.
2. Basic knowledge of clinical regulations and guidance including GCPs, and ICH guidelines.
3. Excellent organizational skills, ability to manage multiple tasks and meticulous attention to detail.

Qualifications

Bachelor’s degree or equivalent and related work experience preferred. Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills.

Working conditions

Office Environment, Laboratory Environment.

May be required to travel up to 15% of the time

Physical requirements

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time.  

The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

Direct reports

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time.