Title: Clinical Research Associate I Location: United States Texas Remote Clinical Monitoring ICON Strategic Solutions (FSP) Remote Job Description: Clinical Research Associate - Home-Based -Texas ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a CRA I at ICON, you will contribute to our clinical trial operations function, working collaboratively to deliver high-quality outcomes across our clinical programs. What You Will Do: Your role will involve delivering clinical trial monitoring work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Working independently and actively to coordinate all activities for setting up and monitoring a study, completing accurate study status reports and maintaining study documentation - Running sponsor generated queries efficiently and taking responsibility for study cost efficiency; you will also participate in the preparation and review of study documentation and feasibility studies for new proposals as required. - Develop and maintain strong, collaborative relationships with key stakeholders, clinical investigators, and site staff. - Ensure patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements. Your Profile: You will bring relevant clinical trial monitoring experience, along with the following qualifications and skills. Required qualifications and experience: - University degree in medicine, science, or equivalent - Knowledge of ICH-GCP guidelines and the expertise to review and evaluate medical data - Excellent written and verbal communication in English - Good social skills enabling you to deal with queries in a timely manner - Willingness to travel as required (approximately 60%) What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family's needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. 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 let us know or submit a request here

Role Description This is a US based remote position and will support the West Region of Hiller. Must be able to work a full time schedule within the hours of 7 am - 5 pm Pacific time to support offices in the Mountain and Pacific time zones. Qualifications - High School Diploma/GED is required - 1+ years’ experience in financial data entry and/or billing - Excellent written and spoken English language skills, with the ability to communicate professionally with supervisors, employees and others individually or in a team environment - Excellent MS Office, keyboarding and data entry skills - Experience with JD Edwards Enterprise One or similar program preferred - Excellent organizational skills, superb accuracy, and attention to detail - Ability to multi-task, prioritize and manage time effectively - Must have the ability to define problems, collect data, establish facts, and draw valid conclusions - Strong math skills and problem solving, focusing on problem resolution rather than just problem identification - Creativity and critical thinking are required - Strong documentation skills - Cheerful, can-do attitude - Ability and enthusiasm to learn quickly - Self-motivated, high-energy, independent worker, and strong team member Requirements - Must be able to sit for long periods of time - Must be able to effectively use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines - Must be able to perform some repetitive motions while using a computer - While performing the duties of this job, the associate is regularly required to talk or hear - The associate frequently is required to sit; stand; walk; use hands to finger, handle or feel; and reach with hands and arms Benefits - Competitive compensation package, including pay advancement opportunities for industry certifications and continuing education - Comprehensive benefits package, including health, dental & vision insurance, retirement plans, company paid & voluntary life insurance, company paid short-term disability, voluntary long-term disability, critical illness & accident insurance and paid time off - Company-provided training, tools and equipment, including $150 annual boot allowance for employees required to wear safety boots in their jobs - Career advancement potential within a growing company

Role Description The Clinical Documentation Specialist is responsible for the evaluation of physician documentation utilizing their clinical expertise to ensure the patients’ severity of illness is accurately portrayed in the medical record for specificity of coding and increased coding accuracy. They provide guidance to the physicians, nursing, and ancillary staff on clinical documentation best practices. They must be self-motivated and be adaptive to change. - Responsible for the day-to-day evaluation of inpatient documentation in accordance with the Clinical Documentation Program requirements. - Ensures the accuracy and completeness of clinical information which is used for measuring and reporting physician and hospital outcomes. - Communicate with members of the medical staff on an ongoing basis to assure the documentation in the medical record adequately reflects the diagnoses being treated and the procedure performed. - In addition to the above job responsibilities, other duties may be assigned. Qualifications - RN, graduate of accredited nursing program and Bachelor of Science in Nursing required within 5 years of hire. - A minimum of three years of experience as a Clinical Documentation Specialist is required. - Clinical experience in multiple areas, particularly in the ICU, is preferred. - Licensed to Practice as a Registered Nurse in the Commonwealth of Virginia. Requirements - Starting Rate: $35.31/hour - Reference Check Process: Reference Checks will be completed by UVA’s third-party partner, SkillSurvey, during the final phase of the interview process. Five references will be requested, with at least three responses required. - Physical Demands: This is primarily a sedentary job involving extensive use of desktop computers. The job does occasionally require traveling some distance to attend meetings and programs. - The starting base rate for this role is $35.31 hourly. Individual compensation will be determined by the selected candidate's qualifications, previous work experience, and/or education. Benefits - Comprehensive Benefits Package: Medical, Dental, and Vision Insurance - Paid Time Off, Long-term and Short-term Disability, Retirement Savings - Health Saving Plans, and Flexible Spending Accounts - Certification and education support - Generous Paid Time Off Company Description UVA Health is a world-class Magnet Recognized academic medical center and health system with a level 1 trauma center. 2023-2024 U.S. News & World Report “Best Hospitals” guide rates UVA Health University Medical Center as “High Performing” in 5 adult specialties and 14 conditions/procedures. - We are one of 70 National Cancer Institute designated cancer centers. - UVA Health Children’s is named by 2023-2024 U.S. News & World Report as the best children's hospital in Virginia with 9 specialties ranked among the best in the nation. - Our footprint also encompasses 3 community hospitals and an integrated network of primary and specialty care clinics throughout Charlottesville, Culpeper, Northern Virginia, and beyond. The University of Virginia is an equal opportunity employer. All interested persons are encouraged to apply, including veterans and individuals with disabilities. Learn more about UVA’s commitment to non-discrimination and equal opportunity employment.

Role Description The Senior Clinical Research Monitor is responsible for monitoring and supporting clinical trials to ensure they are conducted in accordance with study protocols, standard operating procedures (SOPs), Good Clinical Practice (GCP), and applicable regulatory requirements. This role works closely with investigators, clinical research organizations (CROs), hospitals, and internal stakeholders to initiate, monitor, and manage clinical studies while ensuring high-quality execution and compliance. This position can be remote within the US. - Monitor clinical trials at the site level and/or headquarters to ensure compliance with protocols, SOPs, GCP, and regulatory requirements. - Serve as a liaison with clinical investigators, CROs, hospitals, and research institutions to support the initiation and execution of clinical studies. - Review adverse events with investigators and ensure appropriate reporting and documentation. - Manage study timelines, budgets, and schedules; prepare study documents and status reports. - Train investigators and site personnel on study protocols and requirements. - Support implementation of clinical development strategies and assist with clinical evaluation projects. - Identify and recommend qualified investigators and assist with site initiation activities. - Support patient recruitment and retention efforts. - Provide guidance to junior clinical research professionals and may lead or manage assigned projects. Qualifications - Bachelor’s Degree and 4 years of relevant clinical research experience OR Advanced Degree with 2 years of relevant clinical research experience. Requirements - Prior experience monitoring medical device clinical trials. - Experience working with CROs and managing external research partners. - Knowledge of global regulatory requirements (e.g., FDA, EU MDR, ISO 14155). - Experience with electronic data capture (EDC), CTMS, and clinical trial management systems. - Demonstrated ability to manage multiple clinical sites and prioritize competing timelines. - Previous experience mentoring junior CRAs or supporting cross-functional clinical study teams. Benefits - Competitive salary and flexible benefits package. - Health, dental, and vision insurance. - Access to a Health Savings Account and Healthcare Flexible Spending Account. - Life insurance and long-term disability leave. - Dependent daycare spending account. - Incentive plans and a 401(k) plan with company match. - Short-term disability coverage. - Paid time off and holidays. - Participation in the Employee Stock Purchase Plan. - Access to the Employee Assistance Program. - Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.