CTMS and Study Startup Specialist, Clinical Research

Job SummaryThe Clinical Research Startup Specialist is focused on ensuring each study is initiated within the expected start-up timeline and each user has the technical CTMS training and know-how to document study conduct. This role has three components: 1) creating the electronic source (esource) documents, electronic regulatory binder (ereg), and financial builds within CRIO CTMS, 2) deploy initial training and ensure ongoing training of research team members, 3) act as an end-user liaison to support appropriate study start-up and conduct. The CTMS Specialist works in collaboration with the research coordinators, investigators, research compliance, business development, and clinical research operations team to ensure quality assurance in start-up, data collection, data entry, documentation, oversight, and related financial compliance.ResponsibilitiesAssist with clinical research start-up workflow and ongoing support of study opportunities.Build protocol calendars, including protocol amendments and updates to ensure accurate charge capture and segregation of research charges for all research-related patient care as well as ancillary services such as investigational pharmacy.Build study-specific esource templates from a library of prebuilt source templates within the Clinical Trials Management System.Assist with training clinical research staff on Clinical Trials Management System usage, data entry expectations, reporting of issues, and necessary changes.Act as a liaison between end-user groups using the system.Management of investigator database including tracking, managing documentation, and site and specialty associations Inform staff of Clinical Trials Management System updates or enhancements that impact system user processes.Participates in the development and delivery of training and education related to compliance, patient care billing, and invoicing processes.Performs other related duties as assigned or requested.Bachelor's degree or equivalent combination of education and experience2+ years of Clinical Trials Management System experience or at least 2 years of experience coordinating clinical trialsPrevious experience with training other clinical research professionals a plusStrong interpersonal skills with exceptional attention to detail is a mustDemonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) Experience of working with geographically dispersed end-usersFlexibility and willingness to solve problems that fall outside of the immediate area of expertiseAbility to communicate and escalate reports updates/issues to stakeholders regularlyManage multiple competing demandsPractices a high level of integrity and honesty in maintaining confidentialityBENEFITS (full Time)Competitive SalaryHealth InsuranceDental Insurance Disability InsuranceLife InsurancePaid Time OffVision InsuranceWORKING CONDITIONSThis job operates in a remote environment. This role routinely uses standard office equipment such as computers, and phones. Flexibility in hours is allowed, preferably between the waking hours of 9:30 a.m. to 3:30 p.m., with a maximum of 20 hours a week.The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion or belief, national, social, or ethnic origin, sex (including pregnancy), age, physical, mental, or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities.Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.