Clinical Trial Associate
Proclinical is currently recruiting for a REMOTE Clinical Trial Associate with a biopharmaceutical company
- Assist the Clinical Operations team to provide execution of assigned studies, including appropriate filing of all documentation.
- Assist with documents during study start-up, including CDAs and CTAs, in addition to assisting with compilation of regulatory documents and tracking regulatory packages
- Assist with patient tracking to document patient visits and overall study progress
- File essential documents, maintain the TMF, track CRFs
- Aid in organization of Investigators' Meetings and coordinate investigator payments for studies.
- Verify investigator payment details submitted for payment by CROs
- Support Clinical Project Manager and Associate Director with meetings, including preparation of agendas, minutes and action items
- Distribute trial-related materials to study sites
- Support preparation and distribution of newsletters
- Prepare Study File Notebook for review by study team
- Create and maintain tracking tools to monitor collection and expiry of essential documents
- Work with CRO team to obtain required updates
- Create and maintain the Trial Master File and electronic workspace, SharePoint, for each study and the program.
- Prepare, distribute, file, and archive clinical documentation and reports
- Review study files/TMF periodically for accuracy and completeness
- Review site regulatory and essential documents to approve
- Assist with essential document reconciliation at study end
Skills and Requirements:
- Bachelor's Degree is required
- 1+ years of experience in clinical trial operations involving multiple projects in cross functional, multi-site, teams.
- Proficiency in MS Word, Excel, PowerPoint and Project
If you are having difficulty in applying or if you have any questions, please contact Nikki Ranieri at 215-531-5288.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.