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Job #03519

About our client Our client is a publicly traded medical device company headquartered in Pennsylvania that is focused on the development and commercialization of devices used in healthcare testing (i.e., HIV tests, substance abuse kits, oral diagnostic kits, etc.). The company has an experienced management team, a robust line of products and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Senior CRA/Clinical Trial Manager Associate Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities This position will serve as the lead monitor of clinical study sites performing clinical trials for the company and oversees the activities of other clinical trials associates on a study-wide or project-wide basis. Travels to field sites to supervise and coordinate clinical studies. Creates and maintains all study related work materials such as Informed Consent Forms (ICFs), monitoring plans, etc. Creates and maintains tracking tools for management of site-level activities including subject enrollment, monitoring visit conduct, data collection and site close-out activities. Some protocol drafting may be required as will the review and maintenance of all clinical protocols and study documents. In conjunction with other staff members, this position will act as liaison between clinical operations, internal departments, and vendors including contact research organization personnel as required. DUTIES AND RESPONSIBILITIES (include but not limited to): 1) Perform clinical study site monitoring through travel to clinical sites for review of protocol compliance, individual subject source documents and data collected (source data verification), clinical site regulatory and other documentation compliance according to the company’s SOPs. Field monitoring on-site at clinic sites is mandatory. 2) Perform and document: Pre-Study Site Visits for site selection(PSSV), Site Initiation Visits (SIV) and qualification visits, Interim Monitoring Visits (IMVs) and Close Out Visits (COVs) 3) Prepare monitoring reports and follow-up letters to clinical sites in a timely manner. 4) Assume delegated supervisory responsibility from the Manager for execution of monitoring and trial master file (TMF) documentation activities supervising other fulltime/ contracted personnel (as required) 5) Train monitors on protocols, SOPs and study-specific guidelines 6) Review trip reports and performance metrics of study monitors 7) Create mitigation plans if required to assure timely completion of study monitoring tasks 8) Co-monitor clinical sites with company or contracted monitors for quality management as well as workload management 9) Participate in inspections by FDA and Notified Bodies 10) Conduct feasibility assessments for trial design. 11) Recruit potential investigators. 12) Clinical site activity management includes: operational planning for site selection, budget negotiation, study start-up, recruitment and enrollment and clinical document technical writing (trip reports, site instructions, and work instructions as required). 13) Prepare reports for clinical trials and the company management as directed 14) Ensure clinical sites operate compliant to FDA Quality System Regulations and Good Clinical Practice Regulations 15) Handle training of clinical sites regarding investigational and approved assay systems (GCP conformance) 16) Assist with generation of clinical portions of regulatory submission documents. 17) Solve problems encountered at clinical sites or internally during a study. 18) Monitor clinical study portion of project adherence to Design Controls SOP. 19) Create study specific documents essential for the conductance of the trial. 20) Participate in preparation of regulatory submission responses to FDA inquiries. 21) Handle customer/study subject inquiries and advises internal personnel on technical issues and performance of clinical studies. Requirements 1) Bachelor of Science level education, preferably in a scientific or medical discipline (due to technical expertise required for the job) as well as courses in Immunology and Statistics helpful. 2) Strong experience in GCP/GLP, design controls, EU harmonized standards and ICH guidelines 3) 4+ years experience in clinical trial monitoring 4) Supervisory experience helpful