CTI

Title: Senior Clinical Research Associate (level dependent on experience) Location: United States - Remote Job Description: Job Category: Clinical Monitoring Requisition Number: SENIO001893 Full-Time Remote Job Details Responsible for project activities associated with monitoring functions of phase I through phase IV clinical research studies and Real World Evidence (RWE) studies, while continuing to develop knowledge of drug development process, International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs). What you'll do: - Serve as the main CTI contact for assigned study sites - Conduct site visits (pre-study [PSV], site initiation [SIV], interim monitoring [IMV], and close-out [COV]) and complete site visit deliverables with quality and within given timelines in the Monitoring Plan while adhering to all applicable regulatory requirements, SOPs, and ICH GCP - Assist with study start-up activities, including feasibility, pre-study activities, and site selection - Collect, review, and track essential/regulatory documents - Participate in and complete all general and study-specific training as required - Participate in investigator, client, and project team meetings - Create and implement subject enrollment strategies for assigned study sites - Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials - Perform site management activities and provide ongoing updates of site status to the Clinical Project Manager - Conduct remote monitoring and complete the related activities in accordance with study study-specific Monitoring Plan - Utilize systems and reports to track subject status, subject case report form (CRF) retrieval/source document review (SDV), regulatory documents, and IP - Assist with project-specific activities as a member of the Project Team - May support in the development of CRFs and other study-related documents (subject worksheets, Monitoring Plan, etc.) - May support in the translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis, and other study-applicable documents as per required procedures - Where applicable, provide support to the Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions' Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow up on the evaluation process until approval is available. Provide regular updates to the Sponsor/ Client - Assist in preparing and coordinating Investigator and client meetings, and attend meetings as necessary - Liaise with Clinical Data Management for data cleaning activities - Identify site issues and implement corrective actions or escalate as appropriate - Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans - Where applicable, support in contract negotiation with study sites, Investigator payments, and tracking of site payments What You'll Bring: - At least 1 year of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources - Bachelor's Degree or higher in an allied health field such as nursing, pharmacy, or health / natural science, or RN with an Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources - Previous experience in conducting clinical research studies in a hospital setting, a pharmaceutical company, or a CRO - Demonstrated successful performance in a CRA position with a minimum of 1 year of on-site monitoring experience preferred Why CTI? - Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department. - Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work-from-home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program. - Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

• Teaching: Available to teach synchronous online courses via Microsoft Teams • Flexibility to teach in the evenings and weekends, based on the course schedule • Plan and organize instruction in ways that maximize student learning and engagement • Ensure alignment of instructional strategies with CIAT’s adult learner framework, emphasizing certification readiness • Modify, where appropriate, instructional methods and strategies to meet diverse student’s needs • Employ appropriate teaching and learning strategies to communicate subject matter to students via a synchronous online format (Microsoft Teams) • Current certifications in subjects taught • Mastery of Subject Matter: Actively maintain certification(s) in the subject area(s) taught through renewal • Demonstrate a thorough and accurate knowledge of their field or discipline • Connect their subject matter with related fields • Stay current in their subject matter through professional development, through involvement in professional organizations, and attending professional meetings, conferences, or workshops • Curriculum Development: Design, update, and align course materials with college standards for adult learners • Select the instructional materials that align with course objectives • Keep the curriculum up to date • Review course material for accuracy and relevance, providing recommendations for improvements • Ensure compliance with accreditation standards for instructional quality and education. • Adhering to College Policies and Procedures: Ensure Student Database is fully updated and accurate at all times regarding student attendance and grade record information • Maintain compliance with accreditation related to instructional and the quality of education, scheduled class hours requirements and CIAT policies and procedures • Promote collaboration with other staff members and participate in the implementation of new projects, ideas, etc. • Adhere to the CIAT business casual attire. Please refer to the CIAT Employee Handbook for the complete policy. Clothing should be neat, clean, and without rips and holes. We can accommodate polo shirts • Maintain FERPA compliance and handle student data securely in accordance with institutional policy.

• Act as a public ambassador for CIAT on digital forums to connect with current and prospective students and share your experience as an active student • Engage in communications online through LinkedIn, Reddit, Facebook, Twitter, and other platforms with both CIAT students and prospective students • Assist with facilitating group discussions online about your experience at CIAT and the benefits of attending the college. Topics can be programs, courses, instructors, career services, industry certification exam support, and student services • Promote CIAT’s certificate and degree programs, and industry-related resources that align with discussions and posts online • Act as a liaison between Marketing and prospective students, gathering feedback on student needs and interests to optimize marketing efforts • Collaborate with Marketing staff to identify strategies to improve engagement with prospective students in online forums • Report on interactions, communications, and feedback with prospective students

• Conduct one-on-one tutoring sessions to assist students with coursework, assignments, and projects related to computer information systems • Lead small group study sessions to facilitate collaborative learning and problem-solving • Demonstrate a strong understanding of computer information systems concepts, programming languages, software applications, and related subjects • Stay current with course materials and updates students effectively • Create and update tutoring materials such as study guides, practice exercises, and reference documents • Recommend and help develop additional learning resources to support student success • Provide constructive feedback to students on their work to help them improve their understanding and performance • Assist in evaluating students’ progress and adapting tutoring methods as needed • Maintain regular and consistent availability for tutoring sessions • Work with Student Services to schedule and promote tutoring effectively

• Available to teach synchronous online courses via Microsoft Teams • Plan and organize instruction in ways that maximize online student learning and engagement • Modify, where appropriate, instructional methods and strategies to meet diverse student’s needs • Employ appropriate teaching and learning strategies to communicate subject matter to students • Ensure Student Database is fully updated and accurate at all times regarding student grade record information • Promote collaboration with other staff members and participate in the implementation of new projects, ideas, etc. • Adhere to the CIAT business casual attire. • Maintain FERPA compliance and handle student data securely in accordance with institutional policy.

• Plan and organize instruction in ways that maximize online student learning and engagement • Modify, where appropriate, instructional methods and strategies to meet diverse student’s needs • Employ appropriate teaching and learning strategies to communicate subject matter to students • Maintain compliance with accreditation related to instructional and the quality of education, scheduled class hours requirements and CIAT policies and procedures • Promote collaboration with other staff members and participate in the implementation of new projects, ideas, etc. • Ensure Student Database is fully updated and accurate at all times regarding student grade record information • Adhere to CIAT’s compliance requirements to ensure all Federal, State, accreditation, and institutional policies and procedures are being met

• Assist with facilitating small group discussions with students enrolled in similar certificate and degree programs, focusing on shared academic and career interests • Promote job opportunities, internships, and career-related resources that align with students’ certificate or degree programs and career goals • Organize and lead initiatives such as networking events, workshops, and peer-led informational sessions to encourage student engagement in career development activities • Act as a liaison between Career Services and students, gathering feedback on student needs and interests to inform programming and resources • Create and distribute promotional materials for job postings, events, and career resources within the department • Collaborate with Career Services staff to identify strategies to improve student engagement within specific degree programs • Report on student interactions, attendance, and feedback from engagement activities

• Available to teach synchronous online courses via Microsoft Teams on Monday and Tuesday every week • Plan and organize instruction in ways that maximize student learning and engagement • Modify instructional methods and strategies to meet diverse students’ needs • Ensure Student Database is fully updated and accurate regarding student attendance and grade record information • Maintain compliance with accreditation related to instructional quality and CIAT policies • Promote collaboration with other staff members and participate in new projects

• Teaching: Available to teach synchronous online courses via Microsoft Teams • Plan and organize instruction in ways that maximize online student learning and engagement • Modify, where appropriate, instructional methods and strategies to meet diverse student’s needs • Employ appropriate teaching and learning strategies to communicate subject matter to students • Demonstrate a thorough and accurate knowledge of their field or discipline • Connect their subject matter with related fields • Stay current in their subject matter through professional development, through involvement in professional organizations, and attending professional meetings, conferences, or workshops • Ensure Student Database is fully updated and accurate at all times regarding student grade record information • Maintain compliance with accreditation related to instructional and the quality of education, scheduled class hours requirements and CIAT policies and procedures • Promote collaboration with other staff members and participate in the implementation of new projects, ideas, etc. • Adhere to the CIAT business casual attire. Maintain FERPA compliance and handle student data securely in accordance with institutional policy

• Available to teach synchronous online courses via Microsoft Teams • Plan and organize instruction in ways that maximize student learning and engagement • Modify, where appropriate, instructional methods and strategies to meet diverse student’s needs • Employ appropriate teaching and learning strategies to communicate subject matter to students • Current certifications in subjects taught • Lead applicable certification test preparation sessions once a term • Provide regular student support sessions when needed • Responsible for updating applicable course shells, master templates including syllabus, exams banks, discussion questions, assignments, and assessments • Contribute to the selection and development of instructional materials in accordance with course objectives • Contribute to maintaining currency of curriculum, syllabi, and textbooks • Review training material/deliverables and provide recommendations on the accuracy of and relevancy of content of curriculum and performance support tools