We are currently seeking experienced Ophthalmology CRAs to lead and support our Full Service Outsourcing team. Open to major hub locations on the West Coast. 60-70% travel, 8-10 DOS per month. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: - Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - - Responsible for all aspects of site management as prescribed in the project plans - General On-Site Monitoring - Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study - Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements - Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data - Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested - Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs - Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management - Assist with training of new employees, eg. co-monitoring - Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned - Perform other duties as assigned by management Requirements - University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) - 1-3 years of Clinical Monitoring experience - Ophthalmology experience as a CRA - Open to various hub locations The important thing for us is you are comfortable working in an environment that is: - Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. - Changing priorities constantly asking you to prioritize and adapt on the spot. - Teamwork and people skills are essential for the study to run smoothly. - Technology based. We collect our data directly into an electronic environment. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: - Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) - 401(K) - Paid time off (PTO) – Flex Plan - Employee recognition awards - Multiple ERG’s (employee resource groups) - Target Pay Range (based on title): $105-125K Work Environment: - Work is performed in an office environment with exposure to electrical office equipment. - Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: - Ability to sit for extended periods and operate a vehicle safely. - Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. - Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. - Ability to access and use a variety of computer software developed both in-house and off-the-shelf. - Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. - Regular and consistent attendance. - Varied hours may be required. #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

Band Level 3 Job Description Summary This is a Remote Based position. Candidates must be located near an airport (Chicago, St Louis, Detroit, Philadelphia, Baltimore, New York or New Jersey- highly desirable locations). The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials within the country. The Senior CRA is responsible for delivering data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel. LI-#Remote Job Description Key Responsibilities: Trial Monitoring strategy: • Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis) Allocation, initiation and conduct of trials: • Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries • Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures • Facilitates the preparation and collection of site and country level documents • Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required. • Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety. • Accountable for continuously updating all relevant electronic systems to perform job functions • Takes on the responsibility as SME (Subject Matter Expert) as needed Delivery of quality data and compliance to quality standards: • Monitors studies as per current legislations, ICH/GCP and Novartis standards • Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. • Identifies, resolves & escalates issues appropriately • Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry • Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities •Partners with SSU CRA to ensure seamless transition of site responsibility Essential Requirements: • BS/BA degree. Scientific, Healthcare or other related field. • Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA) • Ability to manage multiple priorities and manage time efficiently. • Excellent Site management capabilities with demonstrated negotiating and problem-solving skills • Strong communicator and presentation skills (oral and written) • Fluent in both written and spoken English Desirable Requirements: • Minimum of 3 years of experience in site monitoring strongly preferred • RLT, CAR T or Oncology experience a plus! The salary for this position is expected to range between $108,500 and $201,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click here. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver’s license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings Salary Range $108,500.00 - $201,500.00 Skills Desired Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data Integrity, Decision Making Skills, Lifesciences

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out. • Successful execution of assigned trials and ensuring completion of trial deliverables. • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members. • Mentoring and training of team members. • Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor. • Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities. • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction.

• Management and operational delivery of the clinical elements within a trial including site selection, start-up, enrolment management, site engagement and support, monitoring planning and execution, data cleaning activities and close-out • Successful execution of assigned trials and ensuring completion of trial deliverables • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trial(s) by working in close collaboration with other functional team members • Mentoring and training of team members • Identify challenges to study timelines/deliverables and offer creative action plans to the team/sponsor • Lead CRAs as they establish relationships with their sites for high quality oversight of monitoring, regulatory, IP, site payment and overall site correspondence activities • Maintain team focus on study priorities through efficient cross-functional partnerships and effective communication to achieve the highest level of client satisfaction