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Job #02734

About our client Our client is a global, publicly traded pharmaceutical company with over 100,000 employees. They are at the forefront in the development and commercialization of therapeutics in multiple indications, and are well known for high quality standards and commitment to innovation. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Trial Associate III (In-House) Indiana Salary Highly competitive package, commensurate with experience Responsibilities 1) Perform activities required for the planning, 2) Handle conduct and close-out of assigned clinical investigations 3) Assist with the development of clinical protocols 4) Participate in selecting and qualifying investigative sites 5) Develop Informed Consent documents and negotiate language with investigative sites 6) Manage/coordinate the interaction of appropriate internal departments to support and maintain the clinical investigation(s) 7) Assist with the development of the Clinical Monitoring Plan and coordinate monitoring of assigned clinical investigations 8) Participate in site initiation, closeout and co-monitoring (as needed) 9) Prepare drug-usage projections and track assigned clinical investigations 10) Develop training materials as well as participate in the training of CRAs to ensure consistency and compliance in monitoring of clinical investigations 11) Initiate, prepare and track vendor as well as investigator payments 12) Review documents received from clinical sites and vendors along with routing it to the appropriate personnel 13) Assist in identifying, qualifying and selecting Contract Research Organizations (CROs) 14) Maintain the Trial Master File for assigned studies 15) Enter site and trial information in the Clinical Trial Management System (as needed) 16) Assist with supervision of CROs conducting contracted clinical investigations 17) Prepare and ship drug products in accordance with SOP and DOT regulations 18) Assist in the review of clinical data by preparing data listings and figures (as requested) 19) Track inventory of non-drug study supplies and ship materials (as needed) 20) Assist with the supervision and management of CRO activities for CRO-managed clinical trials 21) Monitor CRO-initiated payments to investigators 22) Assist with submission of safety reports to clinical investigators and FDA 23) Support pharmacovigilance activities for assigned clinical trials 24) Receive safety reports from sites and enter data into safety database 25) Assist in the management and maintenance of the Adverse Event Reporting System 26) Prepare Annual Safety Report, including data reconciliation and construct narrative summaries Requirements 1) Degree or RN 2) Experience in conducting clinical investigations, including the support of project management, site management and pharmacovigilance activities for clinical trials 3) 4+ years of clinical trial experience 4) Experience as a In-House/Junior CRA 5) Superb knowledge of and experience in GCPs 6) Experience in oncology preferred 7) Ability to multitask 8) Keen attention to detail 9) Self-motivated and self-starter