• Oversight of Monitoring Responsibilities and Study Conduct • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock • Serve as the primary point of contact for assigned investigator sites • Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients

• Considered as the primary Sponsor point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning. • Aligns, trains and motivates the site staff and principal investigator with support as needed on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership. • Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure activities with support as needed, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects. • Customize site engagement strategy for assigned study (ies) with support as needed. Gather local/site insights and utilize site engagement tracking tools, to report/track progress and measure impact of that strategy. • Fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. • Identifies, evaluates and recommends new/potential investigators/sites with support as needed from more experienced Site Monitors. • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. • Ensures audit and regulatory inspection readiness at assigned clinical site at all times. • Manages investigator payments as per executed contract obligations, as applicable.

• Collect, analyze, and synthesize data from surveys, interviews, focus groups, administrative data, observations, and site visits. • Collaborate closely with project teams, support client communications, and contribute to proposal development. • Support focus groups, including participant recruitment, logistics, note-taking, and summary reporting. • Design, field, and monitor surveys (online and/or paper), including instrument testing and quality checks. • Analyze quantitative data using statistical software (e.g., R, Stata, SAS, SPSS), including cleaning, merging, validation, and documentation. • Conduct and support interviews and focus groups; analyze and synthesize qualitative data using coding software (e.g., Dedoose, NVivo, Atlas.ti). • Draft reports, briefs, and presentations for technical and non-technical audiences; incorporate feedback and ensure editorial quality. • Create clear, accurate data visualizations and support project teams in using data for decision-making. • Conduct observations and participate in occasional site visits to locations nationwide. • Conduct literature reviews and contribute to research briefs, memos, and other written products.

Role Description The University of Miami/UHealth Department of Public Health has an exciting opportunity for a part time Research Associate 1. The Research Associate 1 supports research activities for the assigned division by conducting laboratory experiments on assigned research projects. The provided research role involves managing the end-to-end qualitative research process, from coordinating stakeholder interviews and ensuring IRB compliance to performing in-depth thematic data analysis and codebook development. - Understands and interprets research protocols and procedures. - Participates in the publication of significant results. - Maintains an overview of relevant research findings. - Ensures all research is undertaken according to good research practice. - Keeps abreast of current publications relative to methods, techniques, and developments within the area of research. - Collects, prepares, analyzes, dissects, and evaluates specimens or tissue cultures. - Operates and maintains laboratory equipment. - Performs a variety of routine assays, tests, and studies. - Performs calculations to complete research test results, collects data, and performs statistical analysis of laboratory results. - Adheres to University and unit-level policies and procedures and safeguards University assets. Department specific functions: - Coordinate and conduct qualitative interviews with regional stakeholders, including scheduling, sending invitations, transcribing recordings, and ensuring compliance with IRB protocols. - Support thematic analysis of qualitative interview data across multiple study regions, including codebook development, coding, and data saturation assessment. - Contribute to the second phase of the BRIDGE Study scoping review, including article screening, full-text review, and systematic data extraction. - Assist with drafting and editing peer-reviewed manuscripts, policy briefs, and blogs targeted at academic and non-academic audiences. - Support dissemination and stakeholder engagement activities, including preparation of materials for international conferences and virtual stakeholder panels. - Assist with coordination of regional working group activities and development of regional roadmaps for pandemic prevention, preparedness, response, and resilience. - Prepare and compile quarterly progress reports documenting study advances and deliverables for the AHF Global Public Health Institute. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. Qualifications - Bachelor’s degree in relevant field required. - No previous experience required. - Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands. - Teamwork: Ability to work collaboratively with others and contribute to a team environment. - Technical Proficiency: Skilled in using office software, technology, and relevant computer applications. - Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders. Benefits - Competitive salaries. - Comprehensive benefits package including medical, dental, tuition remission, and more. Company Description UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the groundbreaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America, and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research, and patient care. We're the challenge you've been looking for. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Part time Employee Type: Staff