Clinical Trial Associate
123 Main Street Allentown, PA 18104
McGrath Systems is accepting applications for a Clinical Trial Associate to work in the Allentown, PA area.
- Assist with the execution of clinical studies such as coordinating, monitoring and oversight to ensure compliance with study protocols, SOPs, ICH-GCP guidelines
- Develop clinical study documents such as study protocols, data collection forms, informed consent forms, monitoring plans, clinical study reports, and any other study related documents.
- Conduct pre-study, initiation, interim, and close-out site visits and complete trip reports and follow up letters in a timely manner.
- Design and provide training to investigators and coordinators during initiation visits.
- Review clinical data for completeness and accuracy.
- Database creation (excel), database entry and limited analysis of clinical data for analytical and clinical studies.
- Set up and maintenance of Trial Master File.
- Assists with generation of clinical portions of regulatory submission documents
- Prepares for and participates in inspections by FDA, Notified Bodies and other regulatory agencies.
- Provide information and status updates to the clinical trials manager and core team members.
- BS in scientific related field
- 2+ years of field monitoring experience as a CRA
- Knowledge of Code of Federal Regulations, Good Clinical Practices, and FDA guidelines pertaining to medical devices and biologics.
- Knowledge of EU Medical Device and In Vitro Diagnostics Regulations.
- Outstanding organizational and time-management skills such as prioritizing/organizing to meet deadlines of multiple projects with overlapping deliverables.
- Ability to effectively communicate orally and in writing at all corporate levels (subordinates, peers, executive management) as well as outside the company.
- Advanced PC Skills (Microsoft Word, Excel and Power Point)
- Ability to travel up to 40% over the year
McGrath Systems is an Equal Opportunity Employer and embraces diversity in the workplace.