This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Research Operations Case Coordinator (ROCC) supports the successful fulfillment of research projects by conducting timely and accurate screenings and logistics management of each donated gift. This role provides guidance and operational support to recovery team members and program managers for research. The position participates in administrative on-call duties and helps maintain processes, strategies, and operational tactics to facilitate completion of research projects. The ROCC collaborates closely with the donor center, tissue recovery, and OPO personnel to support the recovery of biospecimens for the LifeSciences Biospecimens for Research Franchise. Your work will have purpose every single day, contributing directly to life-changing outcomes. Qualifications - High school diploma or GED - Three (3) years of work experience in EMT, hospital corpsman, ER or ICU tech or equivalent, dispatch, or healthcare field - Associate’s degree in Allied Health, LifeSciences, or a related medical field (preferred) - Three (3) years of tissue banking, organ procurement, or related industry experience (preferred) Requirements - Referral Screening: Accurately identify, screen, and process all potential organ and tissue referrals for research, maximizing donation opportunities from both internal and external referring agencies. Communicate with appropriate personnel according to established protocols with exemplary customer service. - Data Entry: Accurately and effectively input research donor referrals into the appropriate internal electronic management systems to track referrals, recoveries, imports, and shipments. - Logistics and Shipping: Arrange and communicate shipment for all recovered organs and tissues with the appropriate parties for both internal and external referring agencies. - Documentation and Record Sharing: Accurately complete research donor information summaries for all recovered donors and share necessary medical records and shipment manifests with appropriate parties. - System Maintenance: Accurately maintain all electronic management systems with correct and timely input of authorized research referrals and dispositions. Benefits - Affordable Medical, Dental, and Vision Coverage - Comprehensive care that won’t break the bank. - Profit Sharing Plan - Share in the success you help create. - 403(b) Retirement Plan - Invest in your future with confidence. - Paid Parental Leave - 6 weeks to bond with your newest family member. - Corporate Sponsored Events - Celebrate milestones and build connections. - Generous Paid Time Off - 18 vacation days, 9 sick days, and 9 holidays. - Flexible Work Program - For approved roles, how and where you perform best. - Tuition reimbursement - We invest in your growth and education. - Career & Leadership Development - Expand your impact and potential. - Wellness Program - Prioritize your health with holistic resources. - Employee Assistance Program (EAP) - Support for you and your household. - Incredible teammates - Collaborate with passionate, dedicated professionals.

• Manage site identification and evaluation. • Develop or review essential study documents including protocols, case report forms (CRFs), source documents, project management plans, monitoring plans, reference tools, and study manuals. • Review site regulatory documents for compliance with CPC Standard Operating Procedures (SOPs) and applicable laws, regulations, and guidelines and to facilitate approval of investigational product release. • Prepare central IRB submissions and resolve IRB issues. • Manage site enrollment and study subject tracking and payments. • Assist with the monitoring of project deliverables and project timelines. • Develop and distribute project documents (e.g. safety reports, lab reports, deviations reports, monitoring reports, follow-up letters, meeting minutes, newsletters, and regulatory documents) • Identify project-specific training for team members and notify appropriate designee to ensure completion and filing of training documentation. • Provide investigational product or device tracking and disposition as required by project. • Develop and manage site and vendor contracts including investigational product (IP) supply, interactive voice/web response system, electronic data capture system, core labs and other applicable clinical services. • Track and approve vendor payments. • Manage multidisciplinary project team members in relation to their role on assigned projects. • Proactively identify issues and discuss resolutions with applicable department heads, project team, CPC executives and/or the sponsor. • Track implementation of resolution through to completion and efficacy checks. • Ensure that the overall quality of project services and deliverables is maintained. • Provide status reports on all projects. • Participate in both onsite and offsite investigator meetings and training sessions. • Escalate budget, proposals and change orders discussions to Business Development. • Assist Business Development with benchmarking for budgets and development of sponsor proposals and service agreements. • Ensure both CPC and sponsor are aware of and in agreement on any change in project scope that has a financial or resource impact. • Routinely advise management regarding the overall project status. • Provide Head of Trial Master File scope of services to enable him/her to establish and maintain Trial Master Files (TMFs) and project document files, both electronic and paper. • Schedule project team meetings and prepare meeting agendas and minutes as needed. • Perform other non-project related general administrative tasks such as filing, copying, faxing and shipping for assigned projects. • Cross-train within the project team, as needed. • Define and monitor Endpoint and Specialty Services scope, timelines and deliverables from project initiation to closeout with assistance from study assigned Clinical Operations Manager and the Head of Endpoint and Specialty Services. • Provide timely feedback on the progress of project assignments; help assess project issues and propose resolutions to the CPC project lead. • Manage contracted deliverables for external committees (e.g. data safety monitoring boards, clinical endpoint committees), including but not limited to meeting scheduling, generation of meeting minutes and distribution of meeting materials. • Oversee SAE process and assure execution of safety plans. • Accurately track receipt, entry, upload and the processing of photos, acetate tracings, and other source documents submitted from sites. • Contact appropriate individuals (e.g., study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing photos, acetate tracings, and other Endpoint and Specialty Services Core Lab documents as required by the project. • Oversee timely and accurate entry and cleaning of data for all study databases; maintain and file data management documentation as required. • Manage the acquisition and supply of project specific materials to study sites. • Provide feedback to study sites on tracing and quality issues, as required by project. • Manage and conduct Endpoint and Specialty Services CPC Core Lab activities.

• Manages clinical research studies to ensure studies are conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines. • Serves as study lead and primary contact for sponsors. • Manages clinical study functions, which may include investigational supply, IWRS/IXRS, data management, biostatistics, pharmacovigilance, and central laboratory. • Generates and presents frequent study status updates and reports to sponsor. • Supervises and provides support to the Clinical team, including Clinical Assistants, In-house Clinical Research Associates, and Clinical Research Associates. • Creates and reviews clinical study documents, including protocols, ICF templates, study budgets, site log/form templates, study manuals and plans, site binders, etc. • Drives and facilitates clinical teamwork and communications to ensure timely attainment of trial milestones. • Identifies issues and develops problem-solving strategies to ensure study timelines are met. • Prepares for and participates in third-party audits and FDA inspections.

• Supervises and supports the implementation of clinical initiatives and/or programs to enhance care coordination, operational efficiency, and quality outcomes • Oversees daily clinical operations and staff to ensure processes are executed consistently in alignment with NCQA standards, state regulations, and applicable contractual requirements • Coordinates and supports clinical, quality, documentation, and data submission activities to support operational and quality objectives • Reviews utilization, outcome, safety, and cost data and escalates identified trends or concerns to leadership for further action • Monitors individual and team performance metrics, identifies performance gaps, and provides coaching or escalates concerns to leadership as appropriate to support operational and quality goals