Clinical Study Specialist I

Clinical Study Specialist I Are you a clinical operations professional who thrives on precision, compliance, and process efficiency? We are looking for an energetic Clinical Study Specialist I to join our growing Clinical Operations team and support the successful execution of innovative oncology clinical trials. Summary In this role, you will be responsible for the operational success and integrity of site-level regulatory documentation, clinical monitoring visits, site initiation visits, close-out visits, and related action item follow-up. Acting as a central liaison between Project Management, Regulatory Affairs (RA), and Quality Assurance (QA), you will ensure that all site initiation activities (SIVs), monitoring preparation, conduct, and follow-up activities, as well as essential document collection (FDFs, CVs, and MLs), are executed with precision. You will own the action item lifecycle, driving compliance and monitoring readiness across a diverse portfolio of complex oncology trials. Responsibilities Monitoring Oversight & Action Item Management: Review third-party monitoring visit reports, log Action Items (AIs), and actively drive them to resolution by following up directly with monitors and site staff Site Startup & Activation ("Green Light"): Manage the collection, quality control, and filing of site-level essential documents (Financial Disclosure Forms, updated CVs, medical licenses, and laboratory certifications) required for Site Initiation Visits (SIVs) and site activation Close-Out Visit & Study Deactivation: Oversee close-out logistics and documentation, ensuring complete reconciliation of all documents and resolution of all outstanding queries prior to formal site closure RA & QA Collaboration: Prepare document packages for Regulatory Affairs (for EC and IRB submissions), track protocol amendments and ICFs, and conduct periodic gap analyses of eTMFs to maintain a constant state of audit readiness System & Logistics Facilitation: Manage site and monitor access to critical trial systems (EDC, IRT, and eTMF) and assist in organising documentation for SIVs and investigator meetings Cross-Trial Process Optimization: Maintain central monitoring dashboards to provide Project Managers with real-time visibility into open action items and study compliance metrics Education Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field Main Requirements 2+ years of hands-on experience in clinical research (CRO or pharma). Experience as a Field CRA, In-house CRA, or Study Startup Specialist is strongly preferred Understanding of Good Clinical Laboratory Practice (GCLP) and Good Documentation Practices (GDP) is required Familiarity with oncology protocols and their associated high-volume documentation (frequent amendments, complex lab kits, and staff logs) Experience navigating eTMF systems (e.g., Veeva Vault) and CTMS platforms Professional fluency in English is mandatory Strong organizational skills, keen attention to detail, and a proactive, solution-oriented approach Working Conditions Full-time position requiring 100% onsite attendance What We Can Offer Competitive wages ($55,400 - $73,800 USD) Medical, dental, and vision benefits 401(k) retirement savings plan with a healthy match Vacation and sick time Employee Assistance Program (EAP) Referral Program About CellCarta CellCartais a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China. Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world! Join us as we make an impact on patient therapy! The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta. CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required to we complete your applicant file, assess your suitability for the role and comply with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact View email address on click.appcast.io. #J-18808-Ljbffr Caprion Biosciences Inc.