• Conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation • Manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.) • Ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs • Ensure audit readiness and develop collaborative relationships with investigational sites

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects • Conduct study initiation visits (SIVs) • Ensure compliance with obtaining informed consent • Perform various study start-up activities such as working with sites to collect appropriate regulatory documents

• Responsible for managing the research activities at sites participating in Worldwide’s clinical research projects • Typically involved in all stages of the clinical study • Conduct study initiation visits (SIVs) • Ensure compliance with obtaining informed consent and regulatory requirements

Role Description The Human Research Technologist - Health and Medicine executes research protocols in support of clinical research trials, studies, and projects. Responsibilities may include: - Designing data collection instruments and implementing data collection procedures. - Performing data analysis and preparing reports and research publications. - Recruiting, informing, and scheduling subjects/participants for studies. - Maintaining subject/participant records. - Overseeing and monitoring laboratory research procedures and recordings involving human subjects to ensure quality control. - Coordinating and reviewing laboratory equipment and supplies to ensure availability for studies. - Documentation of all data variables at all levels of analysis (raw, scored) via Markdown and other systems (Excel, Word, PDF). - Preparing regulatory materials for new projects; addressing regulatory feedback in conjunction with PIs; managing IRB closeout; reading literature; selecting instruments for battery to cover a comprehensive set of topics. - Assisting in preparing datasets; writing results for publication; coordinating manuscript submission procedures; contributing to team meetings to evaluate progress of writing projects and future directions; integrating and accepting feedback from team members. - Routine check-ins with data collection teams to understand capacity, needs, and issues. - Routine check-ins against data collected to ensure high data quality. Qualifications - Associate Degree. - No prior relevant work experience required; previous relevant work experience accepted in lieu of education. Requirements - None required certifications. - Successful completion of background check(s) in accordance with University policies. - Applicants must be authorized to work in the U.S. Benefits - Salary range: $40,608.00 - $58,836.00. - Comprehensive medical, dental, and vision coverage. - Robust retirement plans. - Substantial paid time off including holidays, vacation, and sick time. - Generous 75% tuition discount available to employees and eligible spouses and children.