Clinical Trial Support Specialist

Company: Adaptimmune
Location: Philadelphia
Posted on: March 20, 2023

Job Description:

Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.Clinical development operations lead the delivery of innovative, high-quality clinical development trials at Adaptimmune. In CDO we are committed to making cell therapy a viable option for all eligible patients. We are a highly effective, innovative and fast-moving team that's open to change and new ideas. We work through a culture of cross-functional collaboration to deliver our clinical trials to plan, achieving high quality in everything we do. Everyone in CDO leads by example, where people are inspired to be the best they can be, being curious about new ways of working and being data-driven in decision-making.Primary Responsibility OF THIS POSITIONWork as part of the Clinical Study Team, to conduct and facilitate the smooth running of Adaptimmune clinical trials from study start up through to study close out, in accordance with relevant regulations, SOPs, and study specific procedures. The Clinical Trail Support Specialist will be responsible for assisting the Clinical Scientist with the day to day coordination and administration activities required in the running of Adaptimmune clinical trials.Clinical Trial Support Specialist activities will include but are not limited to preparation of site submission start up packages, interaction with sites to ensure all required documents are in place for site activation, filing of study documents in the study Trial Master File and coordinate and prepare study documentation including ICFs, Study Manuals etcKey ResponsibilitiesStudy Start up

• Support EU/US site pre-qualification
• Assign site and PI numbers
• Review and validate site identification list
• Follow up with site on ethics submission and approval received (initial submission and amendments)
• Review feedback/comments from sites on the ICF to ensure compliance with ADAP requirements; resolve changes requested by the site and approve with support from Clinical Team, safety and legal.
• Prepare, collect and negotiate Confidentially Agreements (CDA) as required. Resolve CSA changes requested by the site and approve any change in CSA language with support from Clinical Team and Legal; Collect internal CSA signatures
• Interface with internal TMF group to ensure site submission package is sent and start up documents are submitted to TMF
• Work with Contract Research Organisation (CRO) to ensure study start up activities are completed within agreed timelines Study Conduct
  • Manage SAE email distribution
  • Ensure good understanding of project scope, milestones, budgets to confirm payment of invoices
  • Submit relevant documents to the Trial Master File
  • Create and maintain Study Procedures Manual and ICF as needed
  • General Clinical Operations Support
  • Liaise with other internal departments to avoid duplication of effort across studies around completion of forms (eg, IBC forms), vendor form updates, etc.
  • Manage the SNAP (subject number assignment program) across studies; Maintain relevant SOP
  • Proactively keep clinical scientists and manager informed about work progress and any issues (including conflicting priorities and free capacity)
  • Maintain a good working knowledge of, and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Adaptimmune SOPs, other Adaptimmune training requirements, and study specific procedures and training
  • Escalate any issues that require immediate action to the clinical scientist
  • Proactively work with team members to meet project goals
  • Support metric tracking and protocol deviation quarterly review
  • Work with CROs and vendors to ensure the smooth operation of ongoing study activitiesQualifications & ExperienceRequired: Bachelor's degree (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experienceSkills & CompentenciesRequired:
    • Client focused approach to work
    • Ability to manage multiple and varied tasks with enthusiasm
    • Attention to detail
    • Strong interpersonal, verbal, and written communication skills
    • Sense of urgency in completing assigned tasks
    • Effective time managementto meet daily metrics, team objectives and department goals
    • Good presentation skillsAt Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

Keywords: Adaptimmune, Philadelphia , Clinical Trial Support Specialist, Healthcare , Philadelphia, Pennsylvania