Role Description Premier Research is looking for a Clinical Research Associate I (Central: IL, CO, MI, KS, TN) to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. Your ideas influence the way we work, and your voice matters here. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Join us and build your future here. What You'll Be Doing: - Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines. - Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements. - Monitors (remote, on site or other approved mode of monitoring) with a focus on data integrity and subject safety in accordance with local/regional laws and country specific regulations. - Plans day-to-day activities for monitoring of a clinical study and sets priorities per site. - Prepares for and conducts on site and/or remote qualification, study initiation, interim monitoring, dosing observation, and close out monitoring visits as directed per CMP. - Works with the Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phase. Qualifications - Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required. - Patient facing, study coordinating experience preferred. - Knowledge of ICH-GCP/ISO14155, FDA Guidance Documents, EU Directives, local/regional regulations, and drug/device development and clinical monitoring procedures. - Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where site monitoring activities will be conducted. - Ability to multitask and work effectively with technology and people in a fast-paced environment with changing priorities, self-starter. - Travel up to 70-85%. - In order to be considered for this position, you must be located in one of the following states: Illinois, Colorado, Michigan, Kansas, Tennessee. Requirements - Please note this position has a tentative start date of July 6, 2026. Benefits - Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $60,000 USD. - The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. - We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off. Company Description Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status.

Role Description As a Clinical Trial Transparency Associate at ICON, you will be responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The Anonymization Specialist will partner with internal and external collaborators on the planning, initiation, and delivery of anonymized documents and datasets in support of the EU Clinical Trial Regulation (EU CTR), ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, and data sharing. - Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements. - Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI. - Work closely with Biostatistics and Programming groups and Medical Writing teams to identify and assimilate the required documents and datasets. - Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance. - Process datasets and documents and apply required transformations. - Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA. - Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications. - Quality check of documents redacted/anonymized by other team members. - Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System. - Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents. Qualifications - Bachelor’s degree in a scientific or technical field. - Minimum 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.). - Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency. - Demonstrated experience in global clinical trial disclosure and transparency processes and systems. - Demonstrated Excel and analytical skills, working knowledge of SharePoint and/or document management systems. - Strong communication, organizational, time management, and project management skills. - Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie, ICMJE). Benefits - 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Role Description Conduct pre‑ and post‑service medical necessity reviews for inpatient, observation, and outpatient hospital encounters using evidence‑based criteria such as InterQual and Milliman Care Guidelines. - Perform retrospective medical record reviews to validate completeness and accuracy of physician and clinical documentation supporting level of care and services rendered. - Identify denial root causes and determine appeal viability based on payer policies, regulatory guidance, and clinical standards. - Prepare, submit, and track clinical appeals, including written appeals. - Collaborate with Patient Access, Case Management, Utilization Management, Coding, and Mid‑Revenue Cycle teams to resolve denials and prevent recurrence. - Research and apply payer‑specific policies, CMS regulations, and contractual language to support appeal arguments. - Track and report denial and appeal outcomes, identify trends, and provide recommendations for process improvement and staff education. - Maintain accurate documentation of all review activities in hospital and payer systems in accordance with compliance standards. Qualifications - Current unrestricted Registered Nurse license in the state you reside. - Requires a University Degree and minimum 4-6 years of prior relevant experience in acute care clinical experience in hospital setting (Relevant experience may be substituted for formal education or advanced degree). - Prior experience in clinical denials, utilization review, case management, or appeals required. Requirements - Bachelor of Science in Nursing. - Master’s degree in Nursing. - Experience with InterQual and/or Milliman Care Guidelines, and electronic medical record systems. - Compact State RN License. - Experience with inpatient level‑of‑care denials, DRG downgrades, and CMS payer rules. - Strong knowledge of hospital revenue cycle workflows, medical necessity review, and payer regulations. - Excellent analytical, organizational, and written communication skills with the ability to independently manage multiple cases. Benefits - Medical, Rx, Dental & Vision Insurance. - Personal and Family Sick Time & Company Paid Holidays. - Position may be eligible for a discretionary variable incentive bonus. - Parental Leave. - 401(k) Retirement Plan. - Basic Life & Supplemental Life. - Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts. - Short-Term & Long-Term Disability. - Tuition Reimbursement, Personal Development & Learning Opportunities. - Skills Development & Certifications. - Employee Referral Program. - Corporate Sponsored Events & Community Outreach. - Emergency Back-Up Childcare Program.

Role Description The Clinical Site Lead drives study execution and operational excellence across Abbott Cardiovascular therapies (Vascular, Cardiac Rhythm Management, EP, Structural Heart, and Heart Failure). Recognized resource in protocol execution, increasing product and disease state knowledge, procedure support (as needed), procedure outcomes and early indication of trends, clinical trial enrollment, and ICH-GCP and clinical research application. Adheres to specified site nomination, qualification, and startup processes. Leads ongoing training/retraining of all site stakeholders to ensure protocol adherence. Continuously reviews, manages, and influences all aspects of site’s recruitment and data collection performance (enrollment, discrepancy resolution, compliance, etc.). Proactively utilizes appropriate operational metrics to minimize screen failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of site initiation, periodic, and close-out visits. May be consulted in the following areas: study design, site payments, site audits, local document review, study documents preparation, and submission to site or competent authority/ethics committee. Main Responsibilities - Develop and maintain a productive clinical territory: - Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels and required data quality. - Understand and assess investigators’ interests and qualifications. - Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code. - Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel. - Provide ongoing technical support to customers and field staff. - Facilitate communication between clinical sites and other Abbott clinical staff (e.g., operations management, study team, Site Contracts Associate), as needed. - Manage all aspects of study lifecycle to include site regulatory and quality: - Start Up: - Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution. - Facilitate all aspects of the start-up process and site initiation visits. - Understand regulatory and legal requirements for study participation at a level that allows for appropriate collaboration with Abbott clinical staff, e.g. Site CRA, Site Contract Associate. - Train facility staff regarding protocol requirements and technology. - Enrollment: - Develop site-specific strategies to promote appropriate patient enrollment. - Identify site successes and challenges and assist in implementing techniques that promote study goal achievement. - Continuously evaluate site study performance and provide timely feedback to site. - Attend study procedures and follow-ups when indicated (or ensure trained personnel attend). - Regulatory and Quality: - Core level Abbott certification and/or equivalent level proficiency. - Develop site-specific strategies to avoid deviations. - Educate site on tools to facilitate compliance. - Provide timely feedback to the sites on key compliance indicators. - Escalate non-compliant sites according to corporate policy. - Collect essential documents, identify and obtain missing data, data corrections, reviewing adverse events and protocol deviations. - Review data and source documentation from investigational sites for accuracy and completeness. - Facilitate resolution of data queries and action items at clinical sites. - Promptly reports the findings of monitoring visits according to Abbott processes. - Maintain accurate, detailed and complete records of monitoring visits. - Provide training and procedure coverage: - Apply clinical and technical expertise to train site and Abbott staff for clinical trials and applicable commercial launches. - As needed, provide clinical and technical expertise for clinical trial procedure support. - Attend study procedures and follow-ups (or ensure trained personnel attend). - Collaborate with commercial partners: - When appropriate, collaborate in the education of local sales groups on new product launches. - When appropriate, contribute to the education of customers on new and existing Abbott products. - Meet with key customers where Abbott GCO presence can elevate the customer experience. - Act as an additional resource for technical questions and troubleshooting. - Identify and adapt to shifting priorities and competing demands. - Remain current on developments in the field of expertise including clinical and Abbott product knowledge, competitive positioning and published scientific and economic evidence. - Maintain at least one area of expertise and function as a local clinical and technical resource. - Possess independent problem-solving skills and ability to make decisions. - Exhibit excellent oral and written communication skills. Qualifications - Associates Degree (± 13 years) Requirements - Minimum 7 years of relevant experience. Preferred Qualifications - Bachelor’s Degree or Master’s Degree in engineering, science, health science, nursing, or a related field, OR equivalent or related experience in cardiology or clinical research. - 2+ years of progressively more responsible relevant clinical trial experience in the cardiovascular field. - Competency in catheterization lab and operating room protocol and procedures. - Ability to travel approximately 75%, including internationally. Benefits - The base pay for this position is $78,000.00 – $156,000.00. - In specific locations, the pay range may vary from the range posted. Company Description Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.