This contract position will provide support for all clinical activities, ensuring the successful completion of clinical trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Central contact for the clinical team for designated project communication, correspondence and associated documentation
- Participate in team meetings and generate meeting agendas and minutes
- Assist with maintenance of databases for appropriate study administration
- Prepare and perform periodic review of the TMF including all GCP-related documents
- Administer all study and related documents (correspondence, monitoring reports, contact reports, and other organizational documents) before and during the study
- Coordinate with external vendors and sites
- Generated/Track Purchase Requests and Invoices based on the requests from Clinical Operations team
EDUCATION, EXPERIENCE AND/OR SKILLS REQUIRED
- Bachelor’s Degree or higher in a relevant field
- 1-2 years of experience in pharmaceutical industry or CRO
- Experience supporting clinical trials
- Basic knowledge of drug development and FDA GCP regulatory guidelines
- Excellent oral and written communication, with particular attention to detail
- Excellent organizational and problem-solving skills
- Proven ability to learn and adapt in an evolving work environment
- Advanced-level proficiency with MS Word, Excel, and Adobe Acrobat
- Familiarity with MS project, MS Visio applications is preferred
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must have demonstrated ability to multitask in high pressure, changing conditions. Ability to use computer, telephone, and other office machines
This is a fast-paced environment with moderate noise level.