Job description

Clinical Trial Associate (CTA) - Temporary

US

Clinical Trial Associate  (Temporary)
Location: Conshohocken, PA

Immunocore is an innovative and dynamic biotechnology company developing a unique platform of T Cell antigen receptor-based therapeutics, called ImmTAXs, as a novel class of treatments for cancer, infectious and autoimmune diseases.

Immunocore has a well- established pipeline of wholly owned programmes, of world leading science and strong IP position, which has led to discovery collaborations with Genentech, GlaxoSmithKline, Medimmune as well as a co-discovery & co-development partnership with Lilly, and recent investment from the Bill & Melinda Gates Foundation.

The Clinical Trial Associate (temporary) will provide support to the Clinical Operations team in the planning, execution, and management of clinical trials and programs.  He/she will work collaboratively with the Immunocore Clinical Project Manager (CPM), Clinical Trial Manager (CTM), Clinical Research Organization (CRO) representative(s), vendors and other Immunocore functional departments (as required).

This is a 6 month position which has the potential to be extended.

KEY RESPONSIBILITIES

  • Assist with review of Site Contracts, Site Budgets, and Site CDA’s
  • Evaluate and approve regulatory documents required for Local/Central IRB Submissions, EC Submissions, through Investigational Product greenlight/ release
  • Assist in providing oversight & accountability to third party vendors assigned to a study or program
  • Ensure TMF Inspection readiness by:
    • Assist with creation of TMF Index and TMF Plan, as needed
    • Conduct periodic TMF document content review for completeness
    • Ensure documents are filed in the correct locations and file naming conventions are correct
    • Assist with quality reviews of TMF
    • Assist in the archiving of study documentation for the TMF
  • May help with coordination of Meetings, and responsible for Agendas, and Meeting Minutes
  • Assist in tracking milestones, generating study metrics, and providing written and verbal updates to Management
  • Liaise with Clinical Project Manager and/or others to resolve study related discrepancies and issues
  • Post disclosure of trial information on publicly accessible websites (e.g., Clinicaltrials.gov)
  • Ensure adherence to pertinent regulatory requirements and to departmental polices, practices and procedures. Ensure knowledge is kept up to date by reading SOP’s and maintaining awareness of GCP guidelines
  • Ensure program meets all GCP/ICH Guidelines and is Inspection Ready

OTHER DUTIES

  • Assist in publishing of Clinical Trial documents, such as Protocols and Amendments, Investigator Brochures, Lab Manual and other study related documentation, as needed
  • Prepare and distribute supportive documents needed by Investigator Sites, and other internal departments
  • Creation of Purchase orders for Clinical Operations vendors, as needed
  • Assist in SOP and working instruction development, review and approval within the company
  • Identify and communicate study issues that will impact budget, resources and timeline

Experience & knowledge

Desirable

  • Knowledge and experience in Oncology therapeutic discipline
  • Previous experience of working in Clinical Research or the Pharmaceutical Industry
  • Previous exposure to eTMF systems
  • Ability to support multiple trials and Programs

Education & qualifications

  • College degree or equivalent combination of education and related experience, required (biological science, pharmacy or other health related discipline)
  • At least 3 years of relevant clinical operational experience in a biotechnology/ pharmaceutical company, and/or CRO
  • Experience must include global/international studies or programs
  • Demonstrated computer skills; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Immunocore IRT and EDC systems and programs

 

Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position. 

 

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