• Monitors clinical trials and observational studies ensuring protocol adherence, managing site activities, and overseeing data collection and integrity. • Ensures sites are conducting the study(ies) and reporting study data as required by applicable regulations and guidelines, and sponsor requirements. • Thorough knowledge and application of project specific protocol. • Performs remote and on-site monitoring in accordance with project specific timelines. • Completes travel scheduling in accordance with project specific and UBC travel policy. • Submits expense reports within UBC requirements. • Attends project team meetings, department meetings and one-to-one meetings with the manager. • Completes site monitoring reports and letters per UBC and/or sponsor SOPs requiring minimal corrections. • Ensures follow-up of site issues and action items per UBC/sponsor timelines. • Enters site visits, site monitoring reports, follow up letter sent date and site contacts into Clinical Trial Management System (CTMS). • Monitors within Electronic Data Capture (EDC) data entry, if applicable, and assists sites with electronic Case Report Form (eCRF) resolution. • Reviews Investigator Site File and performs Investigational Product reconciliation. • Maintains regular contact with assigned sites per study requirements. • Completes all SOP review, training assessments and documentation within requested timelines. • Travel up to 50% required in the European region. • Travel up to 80% required in the North American region. • Completes Site Management and Monitoring activities in accordance with project specific plans and timelines. • Assists with other duties as assigned, which may align with other departments at UBC.

• Performs site qualification, site initiation, interim monitoring, site management activities 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 • 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 • 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 • For assigned activities, understands project scope, budgets, and timelines; 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 study site personnel, or in collaboration with Central Monitoring Associate • 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 • Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions • Knowledge of local requirements for real world late phase study designs • Chart abstraction activities and data collection • Collaboration with Sponsor affiliates, medical science liaisons and local country staff

• Performs and coordinates all aspects of the clinical monitoring and site management process. • Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. • Manages procedures and guidelines from different sponsors and/or monitoring environments (i.e. FSO, FSP, Government, etc.). • Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. • Ensures audit readiness. • Develops collaborative relationships with investigational sites. • Monitors investigator sites with a risk-based monitoring approach.

Job Description Summary Role Summary: The Field Engineer I performs on time and accurate Preventative Maintenance in one or more modalities of equipment. The FE1 is aware of and follows all Field Modification Instructions and/or Instrument Service Information bulletins. Works with experienced Field Engineers, both onsite and remotely, to learn troubleshooting, repair and equipment installation techniques. Responsible for driving customer satisfaction through Service Excellence. Job Description Responsibilities: - Learn to complete on-time and accurate Preventative Maintenance, FMIs and/or ISIs. - Assist more experienced field engineers with equipment installation. - Work with experienced field engineers on basic troubleshooting and service repair needs on designated equipment. - Effectively communicate and partner with teammates and colleagues. - Learn to effectively communicate with customers to ensure resolution and proper follow-up, leading to customer satisfaction. - Partner with the customer and recommend value-added services that will help the customer run their business more efficiently. - Keep up to date on administrative responsibilities such as maintaining customer service logs and internal service records in a timely manner, ordering repair parts, and managing cycle times. - Utilize the GEHC escalation process, as needed, and work closely with region and national support to define and implement corrective action plans to resolve customer issues in a timely manner. - Serve as a member of the account community for key accounts. - Effectively engage commercial counterparts, identify potential sales leads, participate in sales opportunities such as contract renewals, and assist with promoting and implementing revenue programs. - Focus on customer needs and satisfaction, while building on and enhancing the relationship with the customer to ultimately become a perceived partner in their business. - Keep up to date with competitor information and market trends. - Answer service calls independently without assistance within one year of employment. Qualifications: - Associate's or Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field; OR equivalent military education; OR participant in the formal GEHC Biomed/FE Services Internship or Military Externship program; OR High School Diploma/GED and 4 or more years of experience servicing electronic equipment. - Experience with Web applications as well as Microsoft suite of products. - The successful applicant must comply with GEHC's standard background check, including a post-offer drug test. In addition, during employment, the employee must comply with all customer access policies, including but not limited to obtaining and/or providing proof of required immunizations, and additional drug tests or background checks (including a federal government background check if assigned to support a contract with the federal government). Special Physical Requirements: - Candidate must be able to lift, carry, push, and pull up to 35 lbs. unassisted and frequently bend, stoop, twist, climb, crouch/squat, kneel/crawl, sit and stand for long periods of time. Candidate must also be able to reach at, above and below shoulder level, flex/extend neck and have good hand and finger dexterity. Specific vision abilities required by this job may include color, close vision, distance vision, peripheral vision and depth perception. - Must have and maintain a valid Driver's License. - Willingness to be available ""after hours"", or work a rotating On-Call schedule, including weekends, for critical issues and coverage, as necessary. Quality-Specific Goals: - Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. - Meet Health and Human Services, Environment Health and Safety and/or all other applicable regulatory requirements. Complete all planned Quality, EHS & Compliance We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $60,000.00-$90,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes