Study Start Up Specialist

TFS Philadelphia , PA

Posted 2 months ago

TFS is a Global CRO headquartered in Sweden. We genuinely believe that Global in mind and local at heart is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

The Study Start Up Specialist (SSU Sp) is part of Site Management and Start Up Unit, within TFS Develop and will function operationally as a member of a Project Team being responsible of startup activities according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.The SSU Sp must contribute to ensure the planned start up plan is executed maximizing the recruitment window of assigned studies. As part of the job function will perform activities associated with feasibility and site identification, study site initiation process, interact with Ethics Committees or deal with investigator contracts.

Key responsibilities:

  • Performs the startup activities of assigned studies within a country or region ensuring that those are performed on-time, within the scope and in compliance with ICH/GCP guidelines, SOPs and protocol requirements
  • Collect, review, approve process and track regulatory & investigator documents required for study site activation
  • Prepare and complete regulatory process (IEC/IRBs) including ask for requirements to theEC/IRBSs, prepare and collecting specific documentation, submission and amendments, regulatory fees.
  • Collaborate with Regulatory department regarding HA/CA submission/notification.
  • Main responsible of ensuring the quality control of documentation included in any submission/notification.
  • Adapt Informed Consent documents according to local law and document the process following guidelines and SOPs.
  • Ensure contracts are fully executed, regulatory documents and approvals are granted, IPRelease authorized and specific project deliverables are completed.
  • Participate on site evaluation and feasibility process for assigned projects.
  • Review and provide feedback to management on site performance related to start up activities.

Requirements

  • Good knowledge of GCP/ICH guidelines
  • Good Knowledge of applicable regulatory requirements, SOPs and companys Corporate Standards
  • Minimum 1-3 years of relevant clinical experience
  • Previous experience with investigator start-up documents and investigative sites is preferred
  • Excellent written and spoken communication skills in French and English
  • Good organizational skills and experience working with cross functional teams
  • Strong software and computer skills
  • Capable of multi-tasking and working well under pressure to meet deadline coupled with good understanding of working in a team environment

Benefits

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS HealthScience is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients

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Study Start Up Specialist

TFS