SVCHS Clinical Trials Organization - Pennsylvania-Pittsburgh - (23008996) The OCT at University of Pittsburgh is seeking a REGULATORY SUPPORT RESEARCH PROJECT COORDINATOR CT. GOV. This position will provide administrative, regulatory & operational support for OCT, Clinical Research Operations mission.Competencies:  Action oriented, Functional/technical skills, Interpersonal skills, Organizational skills, Analytical skills, Time management, & Written communications. Respects diversity. Working Conditions/Physical Demands: Business Office Setting.Job SummaryOversees submission of regulatory documentation and informed consent documents for the Scientific Review Committee (SRC) and the Institutional Review Board (IRB) and follows-up with investigators to ensure compliance with all policies and regulations. Develops tools and tracking systems for internal study management and maintains research records and files. Responds to routine compliance inquiries and defers moderately complex problems to senior staff.Essential Functions       Assists with assigned aspects of grant proposal development.  Responsible management & supervision of projects as assigned. Reviews progress of projects & initiates appropriate actions to achieve targeted objectives & to ensure on time & on budget project management. Support preparation of grant applications & other grant related activities such as developing grants proposals & fundraising activities if applicable. May work with the administrator, investigator, & institutional offices in grant related activities. Collects & organizes required paperwork for submission if required for the grant. Follows up & coordinates resolution of grant related issues as required. Assist as a Clinical Research Regulatory Support Specialist. Coordinates & monitors all aspects of quality assurance data in clinicaltrials.gov, to ensure compliance with federal, state, & agency regulations & university policy. Oversee the process to provide ongoing support with the management & central maintenance for registration of studies & support researchers in assuring compliance with federal regulations for clinical trial registration with Clinicaltrials.gov. Perform other duties as assigned.Physical Effort Must be able to sit or stand for prolonged periods of time. Must be able to lift up to 25 pounds occasionally. The University of Pittsburgh is committed to championing all aspects of diversity, equity, inclusion, and accessibility within our community. This commitment is a fundamental value of the University and is crucial in helping us advance our mission, which includes attracting and retaining diverse workforces. We will continue to create and maintain an environment that allows individuals to discover, belong, contribute, and grow, while honoring the experiences, perspectives, and unique identities of all.The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity and diversity. EOE, including disability/vets.The University of Pittsburgh requires all Pitt constituents (employees and students) on all campuses to be vaccinated against COVID-19 or have an approved exemption. Visit hr.pitt.edu/contact-ohr to learn more. Assignment Category Full-time regularJob Classification Staff.Regulatory CoordinatorJob Family Compliance & AuditJob Sub-Family Research ComplianceCampus PittsburghMinimum Education Level Required Bachelor's DegreeMinimum Years of Experience Required No experience requiredWill this position accept substitution in lieu of education or experience? Combination of education and relevant experience will be considered in lieu of education and/ or experience requirement.Additional details about Required Licensure/Certification Minimum Qualifications: • A BS Degree in Science, Healthcare or related field. • Familiarity with reading & understanding clinical trial protocols. • Basic understanding of medic l terminology. • Detail orientation & sense of ownership in work. • Strong computer skills including using browsers, Word, & Excel. • Communicate effectively through e-mails & by phone.Work Schedule Monday - Friday, 8:30 a.m. - 5:00 p.mWork Arrangement On-Campus: Teams that work on campus, in an office, or in a lab.Hiring Range $58,979.00 - $98,298.00Relocation Offered NoVisa Sponsorship Provided NoBackground Check For position finalists, employment with the University will require successful completion of a background checkChild Protection Clearances Not ApplicableRequired Documents ResumeOptional Documents Cover Letter