Clinical Trial Associate II

Job Description

Premier Research is looking for a Clinical Trial Associate II to join our Global Clinical Monitoring and Site Management team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success. We are Built for You. We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires. We are Built by You. Your ideas influence the way we work, and your voice matters here. We are Built with You. As an essential part of our team, you help us deliver the medical innovation that patients are desperate for. Together, we are Built for Biotech . Join us and build your future here. Document Management Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organizations or Sponsor s SOPs and all applicable regulatory requirements. Creates and maintain placeholders in the TMF based on TMF filing plans, expired documents, study milestones, site staff changes, and other applicable events. Reviews site documents and verifies they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards. Performs Quality Review and completeness checks of relevant eTMF sections in compliance with company or Sponsor processes throughout start up, maintenance, and close out activities and ensures follow up with clinical team of resolution of findings. Conducts follow up with the internal team on TMF queries to ensure timely resolution. Routinely runs and distributes eTMF reports to clinical team to facilitate quality and compliance. May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out. May support the translation of site documents or reviews translations of site documents, if required. Data entry, Tracking, Reporting and System Support Assists the clinical team with CTMS set up and data entry into project tracking systems, as applicable, including but not limited to site contact updates, site address updates, maintain site assignments and site activation activities, e.g. vendor activities. Assists the clinical study team in the tracking and documentation of Investigators Brochure and safety report distribution as well as other documents/materials sent to sites, e.g. newsletters. Assists with managing and tracking access to systems, (i.e. CTMS, Vendors, EDC, IWRS, etc.) for site staff and clinical team; including conduct of routine reviews, to ensure access removal. Reviews the project specific training matrices and reports to ensure compliance of clinical team. May create CRA workflows to manage site follow up items. Other Attends internal clinical meetings as required and assist with meeting preparation and follow up (decisions, actions, issue logs). Supports the CRA/clinical team in liaising with third party vendors to solve and follow-up on issues e.g. on study equipment, translations. Supports other study specific tracking, such as Q&A log. Participates in available internal training offered to increase therapeutic knowledge. Assists the clinical team with the development of study material, such as create Investigator/Pharmacy site files in collaboration with the study team before Site Initiation Visit; includes working with vendor for creation and distribution of ISF Binders (upload documents, review proofs, trigger shipments). Coordinates general office logistical activities as requested May mentor and train less experienced CTAs May be a point of contact for IT issue resolutions Identifies, manages, escalates issues where appropriate and collaborates with Project Team and Line Manager to identify solutions. May participate in departmental initiatives. Performs additional duties and assignments as required.