• Oversees all aspects of study site management to ensure patient safety is protected, quality of data generated by managed sites resulting in consistently low query levels and in acceptable Quality Assurance reports. • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. • Updates, tracks and maintains study specific trial management tools/systems, and status reports. • If required, manages site start up procedures including the feasibility and recruitment of potential investigators, preparation of EC/IRB submissions, collection and review of regulatory documents, review and adaptation in Patient Informed Consents, notifications to IRB, EC and regulatory authorities, as appropriate, translation of study related documentation, organization of meetings and other tasks as instructed by the Clinical Trial Manager/Project Manager. • If required, assists the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee. • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. • Independently conducts all forms of site visits, including pre-study/ qualification, initiation, routine monitoring, and close-out visits, in accordance with the protocol, local laws, ICH-GCP and Precision SOPs. Prepares and submits for review, accurate and timely monitoring reports from all site visits (on-site and remote). • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs, Clinical Monitoring Plan/Site Management Plan and client requirements. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. • Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. • Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. • Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues. • Develops and maintains good working relationship with investigators and study staff, serving as an ambassador to promote Precision high quality and professional image. • Performs investigational product (IP) inventory, reconciliation and reviews storage and security. • Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. • Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. • Performs data review activities, including remote EDC CRF and patient profiles review, query resolution, and assists data management and clinical data quality personnel to resolve data discrepancies. • Identifies and processes Serious Adverse Events according to the procedures defined by the study team. Also demonstrates a full understanding of the SAE reporting process. • Identifies site risks and escalates those to Clinical Trial Manager/Project Manager with suggested contingencies. Owns the timely and appropriate resolution of the risk with minimal support from project team. • Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. • Travels as necessary according to project needs. • Performs other duties as assigned by management.

Role Description Performs varying standardized laboratory assignments and experiments. - Under direct supervision, performs standard research assignments involving a series of related operations. - Sets up and conducts standard research experiments following detailed technical instructions. - Prepares biological assays and conducts basic quantitative and qualitative analysis. - Maintains records of all tests performed and data collected. - Assists in the compilation and tabulation of data and provides preliminary analysis. - Assembles, calibrates, operates and makes minor modifications to a variety of laboratory equipment as defined by appropriate guidelines. - Adheres to internal controls established for department. - Performs related duties as required. Qualifications - Bachelor's degree in basic science or equivalent; no experience required. Requirements - Biological Analysis - Quantitative Analysis - Qualitative Analysis - Tabulation of Data - Equipment Calibration - Standard Laboratory Equipment Benefits - Salary Range: Commensurate with experience Company Description UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

• Contributes to the selection of potential investigators • In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance • Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study • Trains, supports and advises Investigators and site staff in study-related matters, including Risk Based Quality Management (RbQM) principles • Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study • Ensures the sites are inspection ready at all times • Actively participates in Local Study Team (LST) meetings • Contributes to National Investigators meetings, as applicable • Initiates, monitors and closes study sites in compliance with AZ Procedural Documents • Shares information on patient recruitment and study site progress (site quality/performance) within the LST • Drives performance at the sites • Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate • Updates CTMS and other systems with data from study sites as per required timelines • Manages study supplies (ISF, etc), drug supplies and drug accountability at study site • Prepares study drug for destruction, if applicable • Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Monitoring Plan • If required, determines and discusses with LSAD the correct timing and type of visits • Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study • Ensures data query resolution in a timely manner • Works with data management to ensure robust quality of the collected study data • Ensures accurate and timely reporting of Serious Adverse Events and their follow-ups • Prepares and finalises monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with AZ SOP • Follows up on outstanding actions with study sites to ensure resolution in a timely manner • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, CSP or ICH-GCP compliance issues to Local Management and/or CQM as required • Assists site in maintaining inspection-ready ISF • Prepares for and collaborates with activities associated with audits and regulatory inspections in liaison with LSAD and CQAD • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements • Supports/participates in regular QC checks performed by LSAD or delegate • Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF • Provides feedback on any research-related information including sites/investigators/competing studies that might be useful for the local market • Ensures compliance with AstraZeneca’s Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment) • Ensures compliance with local, national and regional legislation, as applicable • Collaborates with local MSLs as directed by LSAD or line manager

• Assist in the management of the laboratory • Work directly with Dr. Koss to make major contributions to ongoing research projects • Assist with in-vivo experiments • Perform flow-cytometry, western blot, PCR, and cell culture techniques • Maintain supplies for adequate laboratory function and order supplies and equipment as needed • Maintain laboratory safety manuals and equipment • Demonstrate a willingness to learn new concepts and technical skills • Harbor an enthusiasm for working in a team-based environment