Miscellaneous Clinical Job in Westlake Village, California US
Miscellaneous Clinical
Job Description Job Title: Clinical Project Coordinator Position Description The primary responsibility is to assist Management (i.e., Clinical Project Managers, Managers of Clinical Operations) of Clinical Operations with the day-to-day administrative activities that support clinical trials conducted for new product license applications, for line extensions of existing products, and for post-marketing commitments to Regulatory Authorities. Position Responsibilities Track study activities, including: essential study documents, investigational product shipments, CRA monitoring visits, site monitoring visit reports, and study site correspondence. Produce accurate expense reports, site management related documents, meeting minutes, and correspondence with sites as required. Assist with study product shipments, relevant study forms, and study site materials/documentation Assist with submission and preparation of clinical documents for final submissions to regulatory authorities and IRBs/IECs. File study documents in a timely manner, or submit documents for filing, in order to be ready for any impromptu audit Periodic review of study documents in the central files Assist with clinical appendices of various study reports (i.e., final clinical study report) Assemble and distribute Investigator and Pharmacy binders to sites Process Serious Adverse Experience Reports Plan, coordinate, prepare presentations for and attend external meetings for projects Assist with execution of site and vendor contracts, organize study site/vendor payments Assist/submit monthly accruals, if applicable Communicate all relevant and critical issues to management Position Requirements Has familiarity with US Federal Food and Drug Administration, ICH/GCP, and European Regulatory Authority requirements as applicable to a study (or the countries where a study is conducted). Should be able to utilize current applications / systems to compile information for presentation or distribution. Should be proficient in Microsoft Word, Excel, and PowerPoint. Must be able to handle multiple projects at a time and have strong attention to detail. Benefits Blue Cross/Blue Shield Medical and Vision Dental Insurance 401K Plan with Company Match Holiday and Vacation Pay Relocation Assistance Explore more clinical and scientific jobs at RandstadPharma.com