• Manage or assist in the management of large global oncology clinical trials (Phase 1-3), ensuring that studies are carried out in accordance with the protocol, ICH GCP, and local regulatory requirements. • Support key study-related activities and deliverables. • Support implementation of training programs ensuring relevant employees are trained as needed to ensure compliance with the protocol and other study-related documents. • Track study progress and maintain study status updates (e.g., site selection, IRB approvals, regulatory document collection, enrollment, SDV status, study drug inventory, clinical specimen tracking). • Provide progress updates to relevant project teams and present a plan of action for resolution of issues (e.g., trial issues, investigator/study coordinator feedback, monitoring issues, patient enrollment issues). • Maintain and support the eTMF and CTMS platform for clinical studies and operational workflows. • Manage user accounts, permissions, roles and eTMF/CTMS access. • Monitor eTMF/CTMS system performance, trouble shoot issues, and coordinate resolutions with vendor and/or study team members. • Support eTMF/CTMS system upgrades, patches, testing, and validation activities. • Maintain TMF structure and index according to ICH-GCP and Erasca SOPs. • File, classify, and index documents into the eTMF. • Perform ongoing review of trial TMF(s) to assure quality and compliance with relevant SOPs and ICH-GCP. • Track, triage, and resolve missing or nonconformant documents. Collaborate with study team members to obtain required documents and ensure timely filing. • Prepare and support regulatory and sponsor inspections/audits (document retrieval, audit trails, and corrective actions). • May conduct (co)monitoring visits (pre-study, initiation, monitoring, and closeout) with contracted monitors/CRO. • Perform all duties in keeping with the Company’s core values, policies, and all applicable regulations.

Casual Clinical Research Associate Location: 3550 Terrace Street, Pittsburgh, PA Union Position: No Regular/Temporary: Limited Shift: Day Job Work Arrangement: Hybrid Facility: University of Pittsburgh Physicians Department: 50605 UPP06 CCM Researchers Union Position: No Salary Range: $ 24.32-40.54 USD Job Description: UPMC is hiring a Casual Clinical Research Associate to join their Critical Care Medicine team as part of their Multidisciplinary Acute Care Research Organization (MACRO) in Pittsburgh, PA! The Multidisciplinary Acute Care Research Organization (MACRO) provides clinical trial services to principal investigators seeking to maximize the productivity and efficiency of acute care research, from the pre-hospital setting to the ICU and inpatient wards. MACRO offers a wide range of services, including 24/7 screening and enrollment into clinical trials and assistance in the conduct of prospective, observational, patient-oriented acute care research. The Clinical Research Associate will be working in the ICU setting, coordinating interventional clinical trials alongside the APP, bedside nurses, and physicians, and drawing/processing blood samples from patients, overseeing data management of large-scale trials. This is a casual position with no set schedule. This position will work daylight, evening, and overnight shifts depending on the type of patient enrolled into the clinical trial and protocol needs. This position is a hybrid work from home role, but all applicants must be located within 60 minutes of the Pittsburgh area or willing to relocate to this area for onsite needs. Responsibilities: - Create individualized study calendars and reviews them with the patient. - Meet with the principal investigator and Clinical Research Coordinator/Supervisor to review patient status on as needed basis. - Responsible for prompt and accurate data collection for protocols. - Assist coordinator in preparing, sending and tracking documents for re-consenting patients. - Participate in multi-disciplinary meetings to foster educational development by attending relevant seminars, conferences and sponsored educational events as required. - In addition, will contact patient/family members to obtain follow up or survival data information after study completion, and will review survival record data bases to provide follow up. All follow up information is to be documented onto study CRFs and entered into CTMA. - Assist in providing consent forms to coordinators and investigators so that the informed consent process is implemented with study subjects. - Meet monthly with disease center research program leader and research team to present subject trial status. - Facilitate entry of patient on to clinical trials by performing the following tasks. - Complete research requisitions to assist billing department to prevent billing of research procedures to third party payers. - Perform consenting process and study implementation of lab, registry, and non-therapeutic clinical trials. - Perform trial related responsibilities as required such as processing, storing and shipping trial specimens, administers study related questionnaires to study participants (i.e. quality of life, etc.). - Assist in entering subject trial registration and study status updates into CTMA. - Insure that patient's records, slides, radiology tests, lab work results, etc. are obtained and reviewed prior to patient entry onto a study. - Assist in verifying subject eligibility according to protocols by reviewing medical records, laboratory, and radiology or CT scan results. - Complete financial review forms of potential patients to determine insurance coverage for standard of care procedures and completion of requisition forms. - Create study specific source documents, case report forms and study visit checklists. - Facilitate the enrollment of subjects to trials open to the community network sites and will follow up on outstanding data collections. - Facilitate follow-up of protocol patients by developing maintenance-therapy data collection sheets for all protocol patients who require follow-up. - Assist in the coordination of initiation, site evaluation, monitoring visits, and audits required by the sponsor. - Monitor subject compliance of oral study medications. - Assist with obtaining tumor measurements from Radiologist or Investigators to determine response information as per protocol. Qualifications: - B.A. degree in Business, Healthcare, or related or LPN license with a minimum of 2 years of clinical research experience OR - High school graduate with current certification as a Clinical Research Associate from either the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) along with a minimum of two years of clinical research experience Knowledge and use of MS office software products and the ability to work with PC database applications. Excellent organizational skills and be able to work on projects/tasks simultaneously. Highly motivated and be able to work with minimal supervision. Ability to adapt to multiple organizational structures. Ability to meet deadlines and be flexible in response to sudden workload changes. Licensure, Certifications, and Clearances: - Act 34 UPMC is an Equal Opportunity Employer/Disability/Veteran

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. • Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. • May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/Central Monitors) is aware of the contractual obligations and parameters. • Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. • Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. • Participates and presents in key meetings such as Kick Off Meeting. • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. • Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. • Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. • Ensures access and audit trail reviews are conducted as required. • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. • Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs),Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. • Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. • Document requested revisions and approvals in CTMS. • Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. • Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. • Provides solutions for obstacles in protocol execution and site management. • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.

• Provide leadership and direction to clinical site management team members from study start through to closure • Serve as Site Management primary point of contact for clinical monitoring and site activities • Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities • Oversee compliance to the Clinical Monitoring Plan