Title: CLINICAL RESEARCH COORDINATOR I Location: Tampa United States - Moffitt at Magnolia Campus (MCC) - Department ICE-T Data Mgmt - Schedule - Shift - Hours Full Time - Day Shift - M-F 8-4:30PM - Req #: 96802 Job Description: Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer. As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 10,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work for in the Nation, a Digital Health Most Wired Organization and continually named one of the Tampa Bay Time’s Top Workplaces. A National Cancer Institute (NCI)-designated Comprehensive Cancer Center since 2001. Summary Are you looking for an opportunity to impact lives and be a central part of a dynamic and innovative team in the fight against cancer? As a Moffitt Clinical Research Coordinator, you’ll bring hope to patients by delivering tomorrow’s cancer treatments today! You will have the opportunity to interact directly with patients, enroll, educate and guide them through the experiences of taking part in clinical trials while receiving innovative treatments as part of a therapeutic clinical trial. You will be the member of the Team that ensures the trial is moving forward safely, smoothly, and according to plan. Our Clinical Research Coordinators come from a variety of backgrounds and experiences, including social sciences (public health, social work, sociology, psychology, communications, and more), biological sciences, business, and humanities. The Clinical Research Coordinator role is a terrific opportunity for those who have already worked in other areas of healthcare as well as those who are looking for a new and exciting way to contribute through their career. This position offers a Monday through Friday schedule and hybrid work (mix of remote and on-site) after passing a 90-day introductory and training period. Moffitt offers paid training and orientation through its CTO (Clinical Trails Office) Academy. Position tiers may vary according to experience. Relocation assistance may be provided. https://moffitt.org/clinical-trials-research/clinical-trials/clinical-trials-administration/ These positions work closely with patients, patient families, study sponsors (from smaller pioneer biotech companies through large pharmaceutical companies), and the Clinical Trial Team that includes physicians, pharmacists, nurses, data monitors and data managers. Position Highlights: - Coordinate patient care by collaborating with medical staff and document in accordance with standards and regulatory guidelines with direction of a mentor or supervisor. - Act as liaison between the investigators, Moffitt regulatory staff and the sponsor. - Will assist to screen, enroll, and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. - Responsible for data and source documentation and adverse experience reporting. - Perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study protocol. - Will work under general supervision and direction from the supervisor and Principal Investigator to implement and coordinate research, including administrative procedures. Credentials and Qualifications: - *Bachelor’s degree (preferred field of study scientific, health related or business administration program) with one (1) year of relevant clinical, health related, scientific, business or research experience - *In lieu of bachelor’s degree, Associate’s degree with 2 years of relevant clinical, health related, scientific, business or research experience* - CCRP/CCRC or equivalent preferred. Share: Equal Employment Opportunity Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence. Reasonable Accommodation Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Moffitt endeavors to make moffitt.org/careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact one of the Human Resources receptionists by phone at 813-745-7899 or by email at HRReceptionists@moffitt.org. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. If you’d like more information on your EEO rights under the law, please click here.

• Support late-phase clinical development by contributing to protocol development, study start-up, data review and monitoring, and analysis activities • Working collaboratively with the study team and clinical leadership to ensure high-quality, decision-ready clinical data • Assist in authoring clinical protocols, Investigators Brochures, and other regulatory documents ensuring consistency and clarity • Provide input into & implementation of data management plan, CRF design, and data review oversight • Support review, analysis, and presentation preparation of clinical trial data for internal decision making, external interactions, and regulatory submission • Assist Development Lead and Clinical Scientist Director in medical monitoring and management of collaborators, consultants, and/or Clinical Research Organizations in completion of key projects • Anticipate and actively manage problems across a broad spectrum of cross-functional teams • Work cross-functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol, and related documents • Support appropriate training, recruitment, and development requirements for matrix team resources

Role Description This is a field-based position, supporting Abbott’s Vascular division. The Clinical Specialist will primarily be responsible for case planning, case support coverage, and product pull-through throughout the designated territory, and throughout the Region as needed. The Clinical Specialist will promote Vascular products through education, service, and training of customers in the hospital setting. The Clinical Specialist will provide clinical education and sales support in order to assist in achieving projected sales goals, increasing sales revenues within assigned product lines, and increasing market share. This position will have a heavy focus on Vessel Closure. What You’ll Work On - Serves as the technical procedure and product expert in support of case coverage in the hospital setting. - Meet with existing and potential customers (e.g., physicians, physician office groups at hospitals) to identify their clinical needs, goals, and constraints related to patient care and to discuss and demonstrate how Vascular products can help them to achieve their goals. - Develop relationships with hospital personnel; make new contacts in hospital departments; identify key decision makers. - Serve as primary resource for clinical support in case coverage, troubleshooting, and in-service education for company products. - Educate customers on the merits and proper clinical usage of company products by giving presentations and demonstrations using a wide variety of formats and platforms (e.g., slides, transparencies, manuals) to keep all customers abreast of the latest product, therapy, and technology developments and current items of interest in the industry. - Attend clinical procedures in the Cardiac Cath Lab, Interventional Radiology Lab, and Operating Room to ensure customer and patient success with Vascular products. - Respond to customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical research, marketing, product development) to develop optimal solutions. - Support the broader Region as needed with case support in addition to defined territory. Qualifications - Bachelor’s degree or equivalent combination of education and experience - 2-5+ years of related work experience - Ability to travel 50% within assigned region Requirements - Patient interaction experience within a lab/operating room environment - Relevant Technical Certification Benefits - Career development with an international company where you can grow the career you dream of. - An excellent retirement savings plan with high employer contribution. - Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. - A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. - A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Role Description About Surgery: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease, and cancer. Patients are waiting. Your unique talents will help patients on their journey to wellness. We are searching for the best talent for Senior Specialist, Global Clinical Evaluation. The Senior Specialist, Global Clinical Evaluation will serve as an operational excellence subject matter expert across systematic literature reviews, clinical data appraisal and analytics, and medical/technical writing, supporting key deliverables including: - Clinical evaluation reports (CER) - Summaries of safety and clinical performance (SSCP) - Post-market surveillance reports (PMSR) - Periodic safety update reports (PSUR) - New product development (NPD) evidence generation strategies - Premarket approval (PMA) annual reports - Health Authority requests for all therapeutic areas / operating companies / platforms within the J&J MedTech Surgery business unit The Senior Specialist will translate strategy into execution by optimizing processes, standardizing tools/templates, and enabling scalable, efficient delivery models. You will be responsible for: - Driving continuous process improvement of Global Clinical Evaluation processes with a focus on improving, automating, and standardizing literature searching and reporting. - Creating and delivering training to Global Clinical Evaluation and other departments concerning the activities of Global Clinical Evaluation, results of activities, strategic/quality initiatives, etc. - Owning the end-to-end planning and execution of all assigned Global Clinical Evaluation deliverables (e.g., protocols, reports, regulatory responses). - Ensuring timely delivery of high-quality services and documentation as well as consistent deployment across MedTech Surgery. - Developing, implementing, and maintaining relevant procedures and templates, best practice and style standards, reference libraries, reviewer guidelines, and quality control tools/measures. - Managing the utilization and integration of platforms and software supporting systematic literature reviews including statistical analysis tools. - Identifying relevant stakeholders and implementing effective communication models. - Coordinating internal and external Medical Writing resources (writers, reviewers, project management, medical information specialists, librarians, vendors) to deliver against project goals. - Supporting the professional development of internal resources. - Actively partnering with Global Clinical Evaluation teams and cross-functional business partners such as Medical Directors, Medical Safety, Post Market Surveillance, Clinical Affairs, Design Quality Engineers, R&D, and Regulatory Affairs. - Providing technical review of data or reports to be incorporated into Global Clinical Evaluation deliverables and/or regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation. - Working with vendors/service providers to support the introduction of scalable tools, automation, and AI-driven solutions where appropriate. - Tracking key performance indicators, maintaining/monitoring metrics, and reporting issues or opportunities for improvement to leadership. - Ensuring the applicable writing processes are linked to appropriate Quality Systems and Regulatory Processes (e.g., Risk Management, PMS, etc.), supporting data/information accessibility. - Assisting in the management of the Global Clinical Evaluation budget including performing resourcing updates and approving invoices. Qualifications - BA/BS required; advanced degree preferred - 6+ years of experience in EUMDR, clinical evaluation reports, systematic literature reviews, or directly related regulatory/clinical field required - Demonstrated knowledge and experience in narrative or systematic literature reviews (e.g., PRISMA, Cochrane) with qualitative and quantitative synthesis in conjunction with scientific and medical writing required - Demonstrated knowledge and experience in clinical research methodologies with common biostatistical methods, systematic reviews and clinical data appraisal, and medical writing required - Experience with global medical device regulations and guidelines preferred - Change management expertise required - Knowledge of automation / artificial intelligence opportunities relative to medical/technical writing preferred - Regulatory/Notified Body front room audit experience preferred - Experience mentoring medical/technical writers, managing high-volume project work, and supervising internal and external writers/vendors preferred - Position can be performed remotely - 20% Domestic and International Travel required Benefits - Base pay range: $109,000.00 - $174,800.00 - Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)) - Eligible to participate in the Company’s long-term incentive program - Vacation – 120 hours per calendar year - Sick time - 40 hours per calendar year; for employees who reside in Colorado – 48 hours; for employees who reside in Washington – 56 hours - Holiday pay, including Floating Holidays – 13 days per calendar year - Work, Personal and Family Time - up to 40 hours per calendar year - Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child - Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year - Caregiver Leave – 80 hours in a 52-week rolling period - Volunteer Leave – 32 hours per calendar year - Military Spouse Time-Off – 80 hours per calendar year