inVentiv Health Clinical - sponsor dedicated to AbbVieRegional CRA (I,II, Senior)MidWest Region: (OH, KY, TN, IN, MI, WI, IL, MN, IA, MO)Therapeutic Areas: Oncology, Neuroscience, Renal, Immunology, Infectious Disease, Women’s HealthThe Clinical Division of inVentiv Health is a global CRO with a great culture, competitive compensation, comprehensive benefits, a comparably good work-life balance for monitors and ample opportunities for career growth.Program Highlights:Sponsor Dedicated Position -inVentiv employee dedicated to AbbVie6+ months of monitoring experience in a major pharma or CROMust be technically savvyBachelor’s Degree or RN requiredTherapeutic Areas: Oncology, Neuroscience, Renal, Immunology, metabolic disorders, anti-infectives, Women’s Health and HCVWorkload: Protocols & Sites: 2-3 protocols / approx 15 sites / 50- 70% travel both air and car / goal is 8-10 days on site per monthClinical Monitor Job Functions:• Perform routine site visits, including Pre-Study, Initiation, Routine, and Closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.•Document each visit with a quality written monitoring visit report and submit to the reviewer for review and approval within contractual guidelines.•Author and send follow up letter to investigative site documenting the visit and any outstanding items to be addressed within contractual timelines.•Review and approve monitoring visit reports ensuring finalization within contractual obligations.•Assist Project Managers in study execution by acting as Lead CRA on projects and facilitating communication with Clinical Monitoring team.•Perform monitoring evaluation visits with CRAs.•Develop and facilitate training for colleagues on clinical, regulatory, administrative, and company procedures and processes.•Develop study specific tools for tracking and reporting for Clinical Monitoring team.•Participate in feasibility studies.•Develop and write Clinical Monitoring Plans.•Present study materials at Investigator/study launch meetings when required.•Support project management team with assessment of workload and site assignments within the project team.•Assist project management team with review of monitoring reports and study documents when required.•Participate in company-required training programs.•Participate on BID defense meeting.•Perform necessary administrative functions (e.g. submission of expense reports, entering time).•Train/Mentor junior CRAs on monitoring, internal procedures, and query resolution.•Performed regulatory activities, if applicable.To Apply: Please include your updated CV. Candidates will be contacted via email to set up an interview call if selected.
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