Clinical Project Assistant

Clinical Project Assistant

The Clinical Project Assistant requires organizational skills with a high attention for detail. The ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals is necessary. Excellent verbal and written communication skills are essential. Successful candidate will support the Clinical Project Managers, Clinical Research Associates and Study Team for the management of ongoing clinical studies. The Clinical Project Assistant is an integral member of the clinical project team providing support and troubleshooting on various aspects of project

Responsibilities

  • Duties include subject tracking, assembly, review and tracking of regulatory documents, maintenance of study materials and meeting minutes in addition to other activities
  • Set-up, populates and maintains the clinical trial monitoring/management tracking systems
  • Coordinates with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial
  • Assures currency of required clinical trial documents within Central Files (e.g. CVs, FDA 1572, Lab Certification, Financial Disclosure, normal ranges, etc.) throughout the clinical trial. Update study related documentation as necessary
  • Maintenance of project specific regulatory document inventory systems, which includes a precise quality check (QC) process when documents are received
  • Maintains clinical grant tracking database for each study, generates periodic reports on status of grant payments and resolves payment inquiries from investigator sites. Prepares investigator grant payment requests and corresponding cover letters for distribution to Finance and Clinical Investigators
  • Responsible for developing meeting agendas and meeting minutes under direction of Clinical Project Managers
  • Clerical assistance in the process of tracking and filing incoming Serious Adverse Event (SAE) forms, as appropriate
  • Communicate with clients as necessary on any aspect of the clinical trial (including but not limited to, collection of regulatory documents, institutional review board (IRB) submissions, follow up visit reminders, study close outs, etc.)
  • Other duties as assigned

Qualifications

  • Bachelor's degree from a four-year college or university in Business Administration, Life Sciences or related field.
  • One year of clinical research industry experience preferred
  • Proficient in Microsoft Office/Windows and Microsoft Outlook. Specifically: MS Word, MS Excel, MS PowerPoint and MS Project
  • Excellent written and verbal communication skills with ability to work in a global environment
  • Exemplary time management and organizational skills
  • Ability to handle multiple responsibilities and work well under pressure
  • Self-starter, committed to finishing projects completely while meeting project deadlines
  • High attention to detail and level of accuracy
  • High degree of tact, judgment and discretion
  • Must be willing to travel (domestic and internationally) and work evenings and weekends as needed
  • Work requires willingness to work a flexible schedule
City
Lower Gwynedd
State
PA
Job Type
Full-Time Regular
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