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Contract, Clinical Trial Associate

PTC Therapeutics France · New Jersey, United States · Yesterday
Analyst$35–$47/hrContract

About the role

The Contract, Clinical Trial Associate provides clinical study and Trial Master File (TMF) support for clinical operations. This involves supporting Clinical Trial Managers (CTMs) with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment. This position may also provide support in project team meetings by capturing meeting minutes/action items and following up with action item owners to ensure tasks are completed. The incumbent is also responsible for contributing to study budget management. This includes the review of vendor invoices for accuracy against budget, tracking vendor payments. The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. The Contract, Clinical Trial Associate supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

  • Facilitates clinical document management activities, including:
    • Ensuring the proper application of regulatory requirements pertaining to the management of clinical documents
    • Ensuring electronic trial master files (eTMF) are compliant with relevant regulatory requirements by performing periodic and ad hoc reviews/audits of TMF, including reconciliation of the TMF at study close-out
    • Responding to TMF-related inquiries and resolving issues within stipulated timelines
    • Performing quality checks of TMF-related documents, including clinical study site documents, email correspondence, training materials, and other related study documents
    • Applying ICH guidelines to generate filing indices
    • Maintaining current lists of correspondence
    • Contributing to health authority inspection readiness by providing requested documents from the TMF
    • Liaising with Contract Research Organization (CRO) to ensure study-related documents are delivered to the sponsor in a timely and compliant manner
  • Supports CTMs with activities related to: study start-up; investigator site feasibility and selection; essential document review related to investigator site initiation and investigational product release and patient enrollment
  • Assists CTMs with the oversight of CRO(s) and other study-related, third-party vendors to ensure study requirements are met
  • Assists with preparing, editing, producing, tracking and routing clinical documents as required, including clinical protocols, Investigator Brochures and informed consents
  • Assists with the review of monitoring visit reports
  • Prepares and manages clinical study conduct binders that include meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate
  • Reviews vendor invoices for accuracy against budget and liaises with Finance as required to resolve issues, ensure payments are made, etc.
  • Applies understanding of clinical contract terms
  • Performs other tasks and assignments as needed and specified by management

Qualifications

  • Bachelor's degree in a relevant life science or healthcare-related discipline
  • Minimum 2 years of clinical research support experience in a pharmaceutical, biotechnology, or related environment
  • Familiarity with clinical trial study documents
  • Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
  • Proficiency with Microsoft Word and Excel
  • Excellent verbal and written communication skills
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects

Preferred Skills

  • Experience with TMFs, including performing periodic ad hoc, interim and end-of-study reviews/audits on paper and electronic TMFs for several trials to ensure TMF meets sponsor's expectations (includes TMF reconciliation at study close-out)
  • Experience interacting with CROs, including performing TMF QC for Contract Research Organization (CRO) TMF and ensuring quality of the TMF
  • Experience with Microsoft PowerPoint

Pay

Expected Hourly Range: $35 - $47/hour. The hourly salary offered will be contingent on assessment of the candidate's education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

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