Clinical Development Specialist

3 semanas atrás

Curitiba, Brasil beBeeRegulatory Tempo inteiro
Job Title Key Responsibilities:
  • Act as a primary contact for investigative sites and ensure all documents required are collected in a timely manner.
  • Collect and track all the necessary documents, perform quality reviews, format and compile final documents for effective and compliant site activation and maintenance without supervision.
  • Ensure high-quality documents are filed and systems are updated on an ongoing and timely basis, making us ready for an audit at any time.
  • Participate in team and project meetings as applicable.
  • Assist in the strategy definition for Site Activation and provide accurate projections and timelines to study teams.
  • Review and customize country and site-specific patient informed consent forms for compliance with local requirements and protocol. Proactively resolve informed consent issues and other potential difficulties with study sites.
  • May support the negotiation of site contracts and budgets with sites, if applicable, and track progress of contract and budget milestones/developments, intervening and escalating as appropriate.
  • Proactively identifying and escalating to Submission Leads any risk to meeting deliverables.
  • Notify the Submissions Lead of hours identified as Out-of-Scope or overburn.
  • Clinical Trials Information System (CTIS) tasks (specific centralized role for EU): Assist in the upload of submission documentation to, interacting with and monitoring of all notifications and alerts in CTIS to ensure all milestones and events for the trial are met within the timelines mandated.
Qualifications:
  • University/College degree (life science preferred), or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology) AND 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations.
  • Alternatively, candidates with a High School Diploma or equivalent AND a minimum of 2 years' work experience in clinical research, including a strong working knowledge of ICH guidelines and RA, IRB/IEC regulations will be considered.
Experience:
  • Minimum of 3 years of experience in clinical development or start-up/regulatory process.
  • Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines; familiarity with investigator start-up documents and contract/budgets negotiation process; previous interaction with operational project teams and investigative sites.

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