Documentation Associate

Location: US-CA-Westlake Village Job Category: Medical/Health Company: Baxter Healthcare Reference Code: 31240BR Documentation Associate Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives. "Baxter's BioScience division is a leading producer of both plasma-based and recombinant clotting factors for hemophilia, as well as biopharmaceuticals used to treat immune deficiencies, alpha 1 antitrypsin deficiency and other blood-related disorders. Baxter also produces vaccines for the prevention of infectious diseases, as well as biosurgery products used for hemostasis and tissue-sealing in surgery. Baxter BioScience's breadth and depth of expertise in recombinant protein manufacturing, plasma fractionation and proprietary Vero-cell vaccine manufacturing technologies set it apart from other companies in these fields." The primary responsibility is to assist Management of Clinical Operations with the day-to-day 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. Ensure compliance with appropriate SOPs Support Management in meeting company milestones Participate in regular meetings, which may include writing meeting minutes, updating the Clinical Project Database Program and updating project timelines in a timely manner Coordinate/schedule internal and external meetings (i.e., Investigator Meetings, end of study meetings, team meetings, etc.) Communicate all relevant and critical issues to management Process Serious Adverse Experience Reports Assemble and distribute Investigator and Pharmacy binders to sites Track/update study activities, including: CRA monitoring visits, site monitoring visit reports, essential documents, and investigational product shipments, study site correspondence and site/vendor payments Request study site/vendor payments and assist with monthly accruals, if applicable Assist with execution of site and vendor contracts 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 handling/coordinating study product shipments, relevant study forms, and study site materials/documentation Assist with clinical appendices of various study reports (i.e., final clinical study report) Participate in harmonization of SOPs (when applicable) Assist in management of internal and external assessments and any corrective/preventative actions Present to internal/external groups (when applicable) Other duties as required (which may include general administrative tasks) QUALIFICATIONS: 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, and 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. Prefer candidates with AA or BA/BS degree. As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V.