Clinical Project Coordinator
Westlake Village, CA
Req ID 49962BR
Business Title
Clinical Project Coordinator
Business
BioScience
Sub-Business
Research and Development
Country
US
State/Province
California
Location of Position
Westlake Village, CA
Shift_
1st
Job 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.
This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
•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
•Other duties as required
Job 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.
Should have good command of the English language with both excellent written and verbal communication skills. Interpersonal and organization skills are a must. Be able to effectively listen and ask questions for clarification. Be able to provide positive direction to team and identify problems in order to work towards a solution. Be able to produce accurate expense reports, site management related documents, meeting minutes, and correspondence with sites as required. Must be flexible in order to accommodate changes in team and project needs. Regular attendance is required.
Prefer candidates with AA or BA/BS degree or European equivalent education and preferably clinical experience but will consider candidates with no experience.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
