• Responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites • Ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards • Accountable for site management and monitoring, managing investigator site relationships • Serve as the primary point of contact for assigned investigator sites • Interface with the study team, facilitate information flow between members of the study team, vendors and assigned investigator sites • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit • Submit all required reports, documentation, updates and tracking within required timeframes

Purpose: UPMC Hillman Cancer Center is internationally recognized for its leadership in the prevention, detection, diagnosis, and treatment of cancer and is the region's only comprehensive cancer center designated by the National Cancer Institute. As the preeminent institution in western Pennsylvania for the delivery of cancer care, the performance of basic, translational, and clinical research, and the education of the next generation of cancer researchers and physicians, UPMC Hillman Cancer Center is exceptionally well-positioned to contribute to the global effort to reduce the burden of cancer. UPMC Hillman Cancer Center is currently hiring a regular full-time Research Specialist - Budget, ONC to help support the Oncology Clinical Research Services team located at the Hillman Cancer Center in Shadyside/Pittsburgh, PA. This role will support the Financial Compliance team working Monday through Friday daylight hours with a remote schedule. This position is necessary to build clinical trial budgets and coverage analysis for clinical trials. The Clinical Trial Budget Analyst is responsible for ensuring the financial compliance and proper coverage of clinical trial procedures. This role involves reviewing clinical trial protocols to determine what is billable to third-party payers, ensuring alignment with Medicare and other insurance coverage rules, and identifying study-related costs that should be covered by the study sponsor. The specialist collaborates with clinical research teams, finance departments, and compliance to ensure accurate financial planning and billing for clinical trials. This position works with various systems including EPIC EHR and OnCore CTMS for the purpose of segregating charges to ensure compliant billing for research services as well as providing pricing for budgeting purposes. The Clinical Research Services (CRS) team is made up of nearly 200 staff members who facilitate the development, implementation, coordination, internal data monitoring, and completion of oncology-focused trials at Hillman. These trials include institutional (investigator-initiated), multi-center cooperative group/National Clinical Trial Network (NCTN), consortium, and industry-sponsored trials. Using a disease-specific centers model for conducting clinical trials, CRS provides study development and implementation assistance, submissions to the FDA, IRB processing, patient recruitment, study coordination, study-specific training, data collection, and specimen collection and processing. Responsibilities: - Lead the development, analysis, and maintenance of comprehensive clinical trial budgets, ensuring accuracy, consistency, and alignment with protocol requirements, coverage analysis outcomes, and institutional standards. - Build, enter, and maintain study budgets within the Clinical Trial Management System (OnCore CTMS), ensuring synchronization with final protocols, contracts, and coverage analysis documentation. - Conduct detailed coverage analyses in accordance with Medicare’s Clinical Trial Policy, CMS guidelines, and commercial payer requirements to appropriately distinguish study-related costs from routine care. - Apply appropriate CDM and CPT coding to identify billable versus sponsor-covered services, supporting compliant billing workflows and downstream claims review. - Negotiate clinical trial budgets with sponsors and CROs in collaboration with contracting and finance teams, advocating for institutional cost recovery and policy adherence. - Ensure institutional policies, financial compliance standards, and payer regulations are consistently enforced throughout budget development, negotiation, and study activation. - Collaborate closely with investigators, clinical research coordinators, finance, contracting, and compliance teams to resolve budget questions and align financial expectations across stakeholders. - Communicate coverage analysis determinations and finalized budget details clearly to research teams to support accurate study conduct and billing execution. - Support resolution of billing discrepancies or compliance concerns related to clinical trial services by reviewing documentation and coordinating with appropriate teams. - Maintain current knowledge of clinical trial financial regulations, reimbursement guidelines, and payer coverage policies, incorporating updates into budgeting and coverage analysis practices. - Provide education and guidance to research staff regarding clinical trial budgeting, coverage analysis interpretation, and compliant financial practices. - Bachelor's degree in health-related field. - 3 years of experience in clinical trials. - 1 year of experience in Medicare coverage determination preferred. - Knowledge of clinical research protocol and budgeting is required. - Excellent analytical skills with attention to detail. - Strong organizational and time management skills. - Excellent communication and interpersonal skills. - Ability to work independently and as part of a team. - Clinical Research Professional Certification or related certification is a plus. Licensure, Certifications, and Clearances: - Act 34 UPMC is an Equal Opportunity Employer/Disability/Veteran

IQVIA Early Clinical Development is hiring for a Senior CRA 1. Ideal candidates will have Phase 1 experience across a variety of therapeutics. Seeking candidates located Central or West Coast, US. Job Overview We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data. Key Responsibilities - Conduct all types of site visits—selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines. - Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals. - Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues. - Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity. - Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries. - Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. - Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence. - Work closely with cross-functional project teams to support study execution and ensure alignment with project goals. - Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking. Qualifications - Bachelor’s degree in life sciences or health-related field (or equivalent experience). - Requires at least 1.5 years of on-site monitoring experience. - Strong understanding of GCP, ICH guidelines, and regulatory requirements. - Ability to travel as required by the project. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $87,200.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

SHIFT: Day (United States of America) Seeking Breakthrough Makers Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career. CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview This role is responsible for prompt and accurate review of claims in the research billing work queue. Responsible for ensuring that patient charges sent to the research billing queue are sorted and sent appropriately as defined by the Research Billing Plan to either insurance carriers or the research study. Identifies when issues need resolution by the Charge Review Manager and participates in issue resolution. This position is also responsible for providing executive level administrative assistance to the Clinical Research Finance Management office in all aspects of the Department's operations. Serves as a point of contact for clinical research study teams in areas related to research subject registration, providing training on use of the electronic research subject tracking system and resolving issues when they arise. Supports the Department in various functions that ensure SOPs are followed related to billing and research compliance. Collaborates with key department personnel for issue resolution regarding registration, scheduling and billing issues - serves as first point of contact to resolve various questions and issues posed by study team members. May include working with medical records, following HIPPA guidelines. What you will do - Responsible for reviewing and resolving Research charge issues (40%) - Inpatient/Outpatient Research vs. Insurance, must ensure compliance in Research Billing. - Claim analysis of all Research charges for Hospital and physician billing. Make determination to approve charges to Research or third party biller. - Review accounts weekly for potential adjustments, and facilitate those adjustments and insurance company reimbursement to avoid compliance violation fines. - Troubleshoot problem accounts with Investigators, Study Teams, Research, and Hospital personnel. - Support and train study team members in subject registration and scheduling; Register research subjects and encounters appropriately; trouble shoot issues (40%) - Registers and schedules research subjects in EPIC and ensures encounters are linked to research guarantors so that insurances are not charged for research procedures - Responds to phone calls and emails for the department and performs administrative duties to maintain the overall operating function of research registration and charge review - Creates and/or updates patient records by verifying demographic and proper study identification in the registration system. - Performs any other duties necessary to provide efficient, timely services to patients and their families as it relates to the research registration and billing process. - Maintains consistent and productive communication with necessary departments and study teams to resolve issues relating to research registration and billing - Answers general information questions regarding procedures and services (e.g. current studies, study specific information, contact lists, etc.) and appropriately directs calls within the department and institution. - Maintains a working knowledge of current departmental procedures and services and is able to answer questions regarding insurance, registration, and other services. - Responsible for monitoring and measuring the accuracy and integrity of data entered into the registration and scheduling system as well as act as a liaison with other departments to identify quality improvement and training needs. - Works with Management in identifying trends and opportunities to enhance the pre-visit, registration and scheduling functions for patients/subjects and department staff. - Provide executive level administrative support to the CTFM Department (20%) - Attends start up meetings to review and communicate registration and scheduling responsibilities of study team members. - Responsible for serving as a liaison to study teams and research subjects utilizing the research subject participant reimbursement program (PRC) managed by the Department. - Ensures eligibility and compliance to PRC program SOPs in place. - Performs billing charge entry duties for the Department. Under direction of the Charge Review Manager enters billing charges into EPIC for programs set up for special charge entry sessions. - Resolves any registration, billing and charge entry issues with Manager; makes recommendations for edits or process changes when necessary. - Serves as first point of contact via phone or email to resolve various questions and issues posed by study team members. Strives to resolve questions or issue without Manager's involvement. Must be able to handle a large volume of calls and direct them appropriately and efficiently. - Monitors CTFM email inbox. Resolves issues/questions when appropriate or distributes email to appropriate CTFM staff or inbox. Follows up with CTFM staff on resolution of issues. Education Qualifications - High School Diploma / GED Required - Associate's Degree Preferred Experience Qualifications - At least one (1) year of experience in patient registration / customer service Required - Previous experience in Healthcare, registration, Physician billing, or medical records/office Preferred Skills and Abilities - Basic proficiency with office software (Microsoft Office) - Familiarity with electronic medical records systems (EPIC) - Familiarity with research database systems (EPIC) - Basic knowledge of research billing activities - Familiarity with HIPAA regulations - Familiarity with medical terminology - Strong verbal and written communications skills - Strong interpersonal skills - Strong customer service skills - Solid critical thinking / problem-solving skills - Solid analytical skills. - Ability to maintain confidentiality and professionalism - Ability to gather, analyze and make recommendations/decisions based on data - Ability to convey complex or technical information in an easy-to-understand manner - Ability to collaborate with stakeholders at all levels To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more. EEO / VEVRAA Federal Contractor | Tobacco Statement SALARY RANGE: $20.55 - $25.69 Hourly Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. ------------------- At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.