Title: Lead Clinical Research Associate Location: Remote, US, United States Full-time Company Description PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams. This role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality. Responsibilities: - Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures. - Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. - Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. - Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. - Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. - Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. - Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. - Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. - Ensures data integrity and compliance at a site level. - Collaborates with investigator/ site feasibility and identification process, as well as study startup. - Manages Monitors in the query resolution process, including Central Monitoring observations. - Coordinates safety information flow and protocol/process deviation reporting. - Performs clinical supplies management with vendors on a country and regional level. - Ensures study-specific and corporate tracking systems are updated in a timely manner. - Coordinates planning of supervised monitoring visits and conducts the visits. - Manages the project team in site contracting and payments. - Ensures ongoing evaluation of data integrity and compliance at a country/regional level. - Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. - Oversees project team in CAPA development and implementation. - Coordinates project team in process deviations review, management and reporting. - Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. - Delivers trainings and presentations at Investigator Meetings. - Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. - Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. - Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. - Supports preparation of draft regulatory and ethics committee submission packages. Qualifications - Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. - Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. - Experience with all types of monitoring visits in Phase II and/or III. - Strong experience in Oncology preferred. - Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred. - Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. - Full working proficiency in English. - Proficiency in MS Office applications. - Ability to plan, multitask and work in a dynamic team environment. - Excellent Communication, collaboration, and problem-solving skills. - Ability to travel. - Valid driver’s license (if applicable). Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

• Travelling to study sites (Germany-wide) to conduct qualification, initiation, monitoring, and closeout visits in compliance with the approved protocol • Communication with the medical site staff including coordinators, clinical research physicians and their site staff • Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff • Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements • Verification that the investigator is enrolling only eligible subjects • Regulatory document review • Medical device and/or investigational product/drug accountability and inventory • Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol • Assessing the clinical research site’s patient recruitment and retention success and offering suggestions for improvement • Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance.

Role Description The primary responsibility of the Clinical Research Associate I (CRA I) is support of the research team in the conduct of department research projects. - Perform study startup, implementation, and closeout activities - Assist research team with coordination and entry of research data - Assist with regulatory submissions to the Institutional Review Board, and maintain compliance with all federal and local agencies in accordance with Good Clinical Practice guidelines - Interact with patients and families for securing informed consent, scheduling research visits, and collection of data - Maintain documentation for regulatory binder, adverse event reporting, and communications between sponsors and sites - Other special skills specific to assigned research area may include phlebotomy, sample collection, processing or shipping, ECGs, chart abstraction or other duties as assigned - Manage personal career development and administrative tasks Qualifications - Baccalaureate degree or at least 4 years relevant clinical research, professional experience - High attention to detail with strong written and oral communication skills - Strong computer skills beyond basic familiarity with the most common hardware and software systems - Ability to assist staff working on multiple projects - Experience working with pediatric populations (preferred) Requirements - Promotion to next higher level, typically CRA II, is determined by the Clinical Research Program Manager through performance reviews that take into account both experience carrying out the department's job-related duties/tasks, as well as a demonstrated commitment to professionalism in carrying out those tasks in line with Children's values and organizational policies and procedures. Benefits - Medical, dental, vision, retirement, and other fringe benefits - Positions that require night, weekend or on-call work may be eligible for shift differentials or premium pay

Role Description The PRN Clinical Review Specialist provides clinical review support on an as needed basis to assist with an increase in inventory and client demand. This role is responsible for reviewing medical records for medical necessity, level of care, authorization compliance, and payer guideline alignment across inpatient and outpatient services. The position supports timely appeal submissions and inventory management while maintaining quality and compliance standards. Essential Duties and Responsibilities - Perform clinical reviews for medical necessity, level of care, and authorization-related denial. - Review inpatient and outpatient medical records to support appeal submissions. - Apply payer-specific guidelines (CMS, Medicaid, commercial) and internal policies. - Identify documentation gaps and support clear, defensible clinical narratives. - Meet assigned turnaround times while maintaining quality standards. - Document review findings accurately in designated systems. - Collaborate with clinical leadership as needed for escalations or complex cases. Qualifications - Active, unrestricted RN license (compact preferred). - Minimum 4–5 years of clinical experience. - 4+ years of Utilization Review, Appeals, or Clinical Review experience. - Strong knowledge of medical necessity criteria and payer guidelines. - Experience reviewing inpatient and/or outpatient hospital claims. - Proficiency with EMRs and review platforms (Epic preferred). - Strong written clinical documentation and time management skills. Preferred Qualifications - Experience with payer appeals (medical necessity, no-auth, readmissions). - Familiarity with InterQual, MCG, or payer-specific criteria. - Prior remote clinical review experience. - Multi-client or vendor-side experience. - Knowledge of Medicare, Medicaid, and commercial payer processes. Work Expectations - Remote, independent work with defined productivity expectations. Performance Expectations - Timely completion of assigned reviews. - Accurate application of clinical criteria and payer policy. - Clear, compliant documentation. - Ability to adapt to changing inventory and priorities. Physical Demands Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions as described. Regular eye-hand coordination and manual dexterity is required to operate office equipment. The ability to perform work at a computer terminal for 6-8 hours a day and function in an environment with constant interruptions is required. At times, Team Members are subject to sitting for prolonged periods. Infrequently, Team Members must be able to lift and move material weighing up to 20 lbs. Team Members may experience elevated levels of stress during periods of increased activity and with work entailing multiple deadlines.