To assist with assigned Clinical, Regulatory, Quality and Engineering (CRQE) projects and to ensure consistency with international quality standards as well as company policies, standard, commitments and goals.
Essential Functions and Responsibilities
- Develop and execute clinical, regulatory, quality and engineering strategies for client projects
- Develop and write draft documents (e.g. policies, procedures, forms and templates, components of clinical trial summaries and reports, regulatory submissions, abstracts and publications, etc.)
- Track project deliverables using appropriate tools
- Conduct literature searches and draft data review documents
- Complete data entry and checking/verifying accuracy of data
- Ensure tasks are finished on schedule and up to standard
- Other duties as assigned
- Bachelor’s degree in a medical or science-related field or equivalent work experience
- At least 2 year clinical, regulatory and/or quality work experience
- Demonstrated ability to multi-task, prioritize and ensure reliability
- Excellent organizational and time-management skills
- Strong computer skills using Outlook, Word, Excel, PowerPoint, QuickBooks, etc.
- Strong written and oral communication skills
- Passion for clinical research, regulatory and quality affairs activities for pharmaceutical, medical device and food industries
- Ability to interact with client companies, corporate executives and research sites as well as research subjects and Frestedt Inc. staff
- Must be self-directed to secure added training while developing CRQE skills for Frestedt Inc.
- Must be detail oriented and able to work independently
- Able to travel to client sites as needed (less than 20% travel; mostly in TC area)
- Must have excellent critical thinking and problem solving skills
- Able to coordinate training sessions and to secure required training documentation
- Able to reprioritize immediately as new projects arrive
Interested applicants can send their resume and cover letter to firstname.lastname@example.org with the CRQE Assistant in the subject line.