Clinical Trial Manager VCTS Part-Time at Versiti

OverviewVersiti is a fusion of donors scientific curiosity and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute we enable life saving gifts from our donors and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine transplantation stem cells and cellular therapies oncology and genomics diagnostic lab services and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes higher quality services and reduced cost of care for hospitals blood centers hospital systems research and educational institutions and other health care providers. At Versiti we are passionate about improving the lives of patients and helping our healthcare partners thrive.Position SummaryUnder the direction of the Principal Investigators (PIs) and applicable sponsors is responsible for planning and operationally leading the multi-site coordination of research trials from initiation to completion in compliance with applicable regulations and requirements. Manages trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders and sites.Total Rewards PackageBenefitsVersiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical Dental and Vision Plans Paid Time Off (PTO) and Holidays Short- and Long-term disability life insurance 7% match dollar for dollar 401(k) voluntary programs discount programs others.ResponsibilitiesResponsible for regulatory management including the development of IRB submissions pharmacy control plans training materials questionnaires case report forms data analytics infrastructure amendments continuing review study closeout monitoring and reporting of adverse events. Oversees review and approval at partner site(s).Coordination of all study activities with external and internal resources to complete research aims including managing vendor relationships as needed for the conduct of applicable trials (central lab home health etc.)Oversee compliance and conduct of the research protocol. Monitors safety and is involved in reviewing and analyzing adverse events and unanticipated events at participating sites. Provides oversight to ensure confidentiality of data protocol compliance evaluation of problems and complaints.Prepare and manage budgets and provide necessary financial information for grants subcontracts and sponsors. May complete study specific invoicing.Serves as a liaison between Principal Investigator (PI) and stakeholders (sponsors IRB sites etc.) by assisting the PI in day-to-day operations of the projects.Determine data management plans and ensure that all data is collected entered analyzed and reported accurately. Performs quality checks and designs systems to monitor and extract data. May include site visits and auditing of data.Provide training and create documentation to support the research study (training manuals educational promotional materials).Design and maintain databases and systems to manage information data and studies. Evaluate and improve processes for data entry data extraction and record keeping.Generate extract analyze and compose original scientific material for use in abstracts publications progress reports and grants. Participate and present at national and international research meetings and conferences.Supports in planning and conducting Investigator MeetingsReviews and approves release of investigational product or device shipmentsMaintains confidentiality of all subject-related records including written and verbal communications.Coordinates on-site and off-site meetings for project planning purposes and educational events as assigned.Serve as Project Manager (PM) for studies that do not have one also assigned and may provide coverage for others and/or may supervise instruct and direct the work of others including Clinical Research Associates (monitors).As a skilled specialist completes tasks in resourceful and effective ways. Tasks involve forward planning and anticipation of needs/issues.Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classificationUnderstands and performs in accordance with all applicable regulatory and compliance requirementsComplies with all standard operating policies and proceduresQualificationsEducationBachelors Degree in a health sciences biological sciences nursing pharmacy or related field requiredMasters Degree in science or another related field preferredExperience7-9 years Clinical Research Experience in regulatory and industry operations required10 years Healthcare/research experience requiredLess than 1 year Experience with related clinical research preferredKnowledge Skills and AbilitiesAbility to be an effective liaison between study subjects and sponsors investigators health care workers and collaborating professionals requiredAdvanced verbal and written communication skills including the ability to write interpret and explain research studies and procedures requiredAdvanced ability to design implement and manage projects that include planning organization prioritization problem solving and performance of project tasks to ensure project completion within designated timeframes requiredVery strong attention to detail and ability to evaluate and ensure accuracy of data related to laboratory results subject health history and data collection and reporting requiredAbility to evaluate and extract data from medical records with ability to spot errors and trends and address promptly requiredStrong knowledge of regulations associated with human subject research requiredAbility to work in an independent manner while providing mentorship to others requiredTasks involve a considerable degree of forward planning and anticipation of needs or issues requiredLicenses and CertificationsACRP CCRC or CCRA or SOCRA CCRP Certification upon hire requiredTools and TechnologyPersonal computer (laptop) requiredGeneral office equipment (computer printer copy machine) requiredMicrosoft Suite (Word Excel PowerPoint) requiredElectronic Data Capture systems such as Redcap Medidata Inform etc. requiredElectronic Trial Master File systems such as Florence eBinders requiredElectronic consent platforms such as Redcap or Florence eConsent requiredEPIC medical record system preferredRequired Experience:Manager Key Skills Bidding,Apps,Benefits,Corporate Recruitment,Android Development Employment Type : Part-Time Experience: years Vacancy: 1