• Develop and manage study timelines, budgets, and resource plans • Coordinate with internal stakeholders (e.g., product, regulatory, marketing, data) to align study objectives with business goals • Proactively identify risks and implement mitigation strategies • Author core clinical study documents, including protocols, informed consent forms (ICFs), and case report forms (CRFs) • Lead full study lifecycle execution from startup through closeout. • Prepare and manage IRB submissions, amendments, and continuing reviews • Ensure studies are conducted in compliance with GCP and applicable regulatory and ethical guidelines • Design and oversee clinical data systems, including EDC and eTMF

Role Description SystImmune is seeking a high quality, ambitious and experienced Clinical Research Associate II (CRA II) to support SystImmune’s clinical trials. The CRA II is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The CRA II must be self-motivated, independent, and able to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities. - Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits - Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team to ensure efficient preparation and delivery of study materials to investigator sites - Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug - Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.) - Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions) - Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication - Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries - Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence - Identify and complete follow-up of SAEs at study sites - Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities - Ensure appropriate and timely submission of documents to the Trial Master File - Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Qualifications - Bachelor’s degree in health science or related field. - 2+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits. - Excellent verbal and written communication skills required. - Excellent organizational, multi-tasking and time management skills required. - Demonstrated experience developing/maintaining site relationships and securing compliance. - Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines. - Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF). - Ability to travel as required (50-75%). Benefits - The expected base salary range for this position is $80,000 - $110,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills. - While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.

Role Description Join TriHealth as a Facility Clinical Documentation Specialist! In this role, you’ll collaborate closely with clinicians, leaders, and operational teams to strengthen documentation practices, optimize charge capture, and support compliant, high-quality patient care. Your expertise will directly influence organizational performance while allowing you to lead education, process improvement, and system-wide initiatives. The Facility Outpatient Clinical Documentation Specialist (CDS) is responsible for activities which assist the organization with processes for complete and accurate capture of documentation and charges in a compliant manner for the outpatient services rendered. The Outpatient CDS assists clinical areas to understand the relationship of documentation, medical necessity, coding, and charging for all services provided to the highest specificity. The Outpatient CDS provides education and training of staff related to these areas of oversight as well as coordinates with clinicians and providers for ongoing education. The CDS will also coordinate process mapping including information systems flowcharts, revenue capture responsibilities, and charge analysts’ functions. Qualifications - Bachelor’s Degree - Registered Nurse or Licensed Practical Nurse, or Registered Health Information Administrator, or Registered Health Information Technician, ACDIS - Association of Clinical Documentation Integrity Specialists credential, or Certified Professional Coder, Certified Outpatient Coder, or Certified Documentation Expert Outpatient - General understanding of hospital-based outpatient charging, coding, and/or revenue capture functions - Knowledge of APC and OPPS reimbursement structures (preferred) - Strong project management skills - Strong interpersonal skills, with demonstrated success at communicating effectively with all levels of the organization, especially senior leadership and department heads - Skilled ability and comfort with electronic medical records (EPIC preferred), and hospital billing functions - Proficient with personal computer applications (Excel, Word, and PowerPoint) - Effective organizational skills with the ability to prioritize and manage multiple functions and responsibilities simultaneously - Ability to organize and work with minimum supervision at a high level of motivation and initiative while being entrepreneurial, creative, and results-oriented - Strong problem-solving and investigative skills - 5-7 years’ experience of healthcare knowledge typically obtained from experience as a clinical caregiver or manager, coding specialist, and/or a revenue integrity team member Requirements - Regularly conduct chart reviews of clinical departments to review documentation and charge accuracy - Perform shadowing and coaching with key stakeholders in the clinical departments - Perform revenue optimization functions including: - Review of accounts for potential missing documentation, coding, and charging - Identify root cause of missing charges - Educate Clinical and Ancillary Departments - Perform process improvement activities aimed at revenue optimization - Coordinate with the Clinical Departments, Coding, CDM, and other key stakeholders to address and resolve root cause issues - Analyze patient clinical and billing data and conduct chart reviews to identify documentation, coding, and charging opportunities - Summarize findings, prepare reporting and feedback for clinical departments and finance teams - Coordinate projects to build upon documentation improvement and charge capture processes for identified areas of opportunity - Develop and maintain project plans and project tracking, including documentation of project meetings and project issues lists - Maintain current knowledge of applicable regulatory standards, which may impact utilization of processes and systems Benefits - Comprehensive benefits package including medical, dental, vision, paid time off, retirement plans, and tuition reimbursement

Role Description Position in this function is under the supervision of the Part D Pharmacy Manager - Health Plan Services, this position is primarily responsible for performing and/or supervising pharmacist activities related to all Pharmacy Quality Initiatives (i.e. RxQI, MTMP, Adherence, Hospital Discharge Prgm, Fraud Waste and Abuse monitoring, Part D coverage determination and appeals processing) for Kelsey-Seybold Clinic and/or KelseyCare Advantage. This position will oversee program staff as well as monitor and report ongoing progress of pharmacy quality initiatives. This position will also perform operational maintenance and/or implementation of new clinical services as well as any additional duties deemed necessary for the Pharmacy Services Department. You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. Primary Responsibilities: - 40% Responsible for conducting clinical pharmacy services through Pharmacy Quality Initiative Programs, including: - Review of all current medications - Review pharmacy claims in contracted PBM systems - Drug-drug interactions screened - Therapeutic alternatives recognized - Communication with physician regarding drug therapy - Patient counseling - Medication reconciliation within EPIC (medical chart) - Follow-up with member - 10% Answer inbound calls and conduct outbound calls regarding processing of coverage determinations, including: - Review medical information essential for coverage determination - Properly enters data into software program(s) - Enter overrides in appropriate systems to process payment - Generates letters and/or reports - Works all appropriate program workflow steps and queues as assigned - After hours/weekend coverage as assigned - 10% Communicate with physicians and other healthcare personnel to discuss: - Specific medication recommendations - Therapies for cost-effective care - General drug information - Educate about health plan prescription drug benefits - 10% Monitors and evaluates claims for appropriate use by members, physicians, and pharmacies, including: - Conducts drug utilization review of potentially fraudulent claims, abuse, and/or waste - Assists in reviewing claims adjudicated by the PBM to ensure payment for formulary products are processed correctly - Perform audits - Reports risks to management - 10% Communicates instructions to internal and external individuals and/or departments, including: - Furnishes and obtains information from other entities/vendors - Maintains staffing and program schedules - 10% Assists in the development of clinical pharmacy program enhancement and better practices within the department, including: - RX Quality Initiative (RXQI) - Pharmacy Quality Initiative Programs (QIP) - Adherence Programs - Medication Therapy Management Program (MTMP) - Hospital Discharge Program (HDP) - Fraud Waste and Abuse (FWA) protocols - Coverage Determination (CD) processes - 5% Provide program training and oversight, including: - Training and oversight of program staff, pharmacy residents, and assigned interns as needed - Assists in scheduling of Health Plan Pharmacy Services Department personnel to ensure program productivity - Monitor daily duties and program work queues to ensure program requirements and department goals are achieved - Create program reports weekly, monthly, quarterly, annually or upon request from management - Communicate program and staff concerns to management - 3% Provides clerical support for Part D duties and audits, including: - Administrative and clinical support for special projects - Responsibilities include attending and scheduling meetings, calendar management, dictation, answering phones and routine questions - 2% Ensures prompt and courteous customer service by all Health Plan Pharmacy Services personnel, including: - Responsible for compliance to federal and state Pharmacy laws - Triages patient emergencies and provides the appropriate follow up as needed - Responsible for adherence to federal and state Pharmacy laws Qualifications - Pharm D. degree - Current and Active Pharmacy License - TSBP Registered Pharmacist - 3+ years operational pharmacy benefit experience, clinical and/or retail pharmacy experience - Customer Service Experience - Proficient with computer applications that include, but are not limited to: Microsoft Word, Excel, and Access - Proven ability to communicate verbally and in writing with Health Plan Pharmacy Services Department personnel - Proven ability to communicate with physicians and other healthcare personnel - Proven ability to communicate verbally and in writing with members/patients/vendors - Proven to write reports (i.e., weekly/monthly), maintain audit logs, perform oversight and communicate concerns - Proven good Alpha/Numeric data entry skills with minimal errors - Demonstrates solid multitasking, problem solving & analytical skills - Proven ability to lead others on team - Proven detail oriented with good verbal and written communication skills - Proven ability to communicate with all levels of the Management - Proven excellent organizational skills - Proven high Stress Tolerance Requirements - Completion of a Managed Care Pharmacy Residency Program or Pharmacy Practice Residency Program (PGY1) - ASHP Immunization Certification - BLS CPR Certification - 3+ years of HMO 3rd party managed care experience - 3+ years of Medicare Part D experience - Experience with prior authorization, coverage determination and appeals processing - Experience with vendor relations - Customer Service experience - Auditing experience - Supervisory or management experience - Knowledge of Medicare regulations with emphasis on Part D formulary, coverage determination and appeals processing - Knowledge of the Pharmacy Benefit Management (PBM) industry - Knowledge of Medicare 5-star ratings and HEDIS measures - Staff Management Benefits - Comprehensive benefits package - Incentive and recognition programs - Equity stock purchase - 401k contribution (all benefits are subject to eligibility requirements) Application Deadline This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.