Clinical Trial Assistant
Job Opportunity at Spark Therapeutics, Inc

Posted on Mar 16

http://www.sparktx.com    215-220-9300

Location: Philadelphia, PA
Job Type: Full Time
Job ID: W4152794

The clinical trial assistant is responsible for providing broad support for clinical trial management. S/he will assist the clinical project managers and other members of the team with day to day clinical trial execution and maintenance activities.

Clinical trial support:
  • ensures study documents are tracked, file, maintained, and archived in audit-ready condition; maintains clinical trial masterfiles
  • assists with handling queries from sites and provides site support as needed; prepares materials to assist sites with IRB/IBC submissions
  • develops and maintains study-specific forms and files; assists with clinical document generation, review and revisions
  • provides initial quality control (QC) of operational data
  • assists with clinical compliance to SOPs, procedures and regulatory requirements by actively requesting and completing required forms and documents
  • facilitates written and verbal study communication to internal program team/functions, CROS, vendors, site personnel, and consultants
  • attends study team, development/strategy team and departmental meetings
  • assists project managers/teams as needed
  • assist with quality assurance audits
  • assist with logistics for vendor meetings, site meetings, etc
  • post and maintain study-related information on external information sources (eg, websites) as necessary
  • participate in departmental initiatives as requested
  • assist with clinical supply documentation, ordering, management, and tracking
  • processes, logs and distributes completed case report forms
  • Other duties as assigned

  • Strong initiative and “can do” attitude; professional work ethic
  • Organized and efficient; excellent attention to detail
  • Strong verbal and written communication skills
  • Excellent people and customer service skills

  • Bachelor’s degree in a scientific discipline or equivalent nursing degree required.
  • Familiarity with the pharmaceutical industry, clinical research, and/or clinical trials is desirable
  • Proficient in Microsoft Office applications


Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team


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