• Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. • Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase I to III studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes. • Ensures regulatory inspection readiness at assigned clinical sites. • 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. • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members. • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes • Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate • Demonstrates diligence in protecting the confidentiality of each subject/patient • 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 • Assesses site processes • Conducts Source Document Review of appropriate site source documents and medical records • Verifies required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records • Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines • Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture • Verifies site compliance with electronic data capture requirements • May perform 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 • 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 • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan • 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 • Understands project scope, budgets, and timelines for own and others’ activities in the clinical team; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met • Must be able to quickly adapt to changing priorities to achieve goals / targets • May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate • Prepares for and attends Investigator Meetings and/or sponsor face to face meetings • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions • May provide training or mentorship to more junior level CRAs

• Responsible for site qualification, initiation, interim monitoring, site management, and study close-out visits • Provide mentoring and guidance to less experienced CRAs and site staff when needed • Document site visit findings via written reports • Assess, monitor, and train study site staff on protocol adherence as required • Review study subject safety information and informed consent • Conduct source document verification for compliance, patient safety, and veracity of data • Review CRFs using paper or electronic data capture systems and assist sites with data query resolution • Ensure site compliance with IP receipt, accountability and return or destruction • Conduct accompanied site visits for assessment or training of other CRAs as requested and appropriate

• Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness • Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites • Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials • May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs • Promptly document monitoring activities and submit/approve visit reports • Manage site essential document collection and TMF reconciliation with site files • Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals • Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution • Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans • Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations • Support sites and the client's regulatory inspections • Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities • Lead site engagement initiatives and foster relationships with key Oncology sites and networks