Project Coordinator I

DEPARTMENT: Medical Writing

REPORTS TO: Department Supervisor/Manager or Director


Assist in the coordination, organization, and prioritization of study tables as well as assist in the review of in-life data.  This is an entry-level position with the expectations of supervised and/or semi-independent functionality, demonstrating a comfortable level of project coordinating and writing skills in the Medical Writers Department.

  • Assist in the quality control (QC) of in-life data in accordance with SOP, GLPs, and protocol standards.  Also assist to ensure that the appropriate person(s) receive and make corrections to data before returning to Study Director and/or QA. Assist in meeting data submittal timelines through the coordination of data review.
  • Participate in the general data overview during procedures as appropriate (ie, assisting in the in-life QC process of study records on a daily basis for compliance with SOPs and/or protocols).
  • Assist in the assembly of in-life tables for reporting purposes as well as the final preparation of the study binder.
  • Assist in the administrative tasks (i.e., back-up assistance in Test/Control Article log-in and study shipment process, scanning items for Study Directors and/or Medical Writers).
  • Assist/coordinate Sponsor requests to aid Study Directors.
  • Assist in interdepartmental collaboration; ensure effective communication, process improvement, and data flow/transitions.
  • Organize CBSET and outside vendor paperwork.
  • Assist in the coordination and relative responses to in-life QAIRs to ensure that the QAIRs are addressed in a timely manner.
  • Assist in/communicate the updating of data timelines on PC Assignment Excel spreadsheet.
  • Assist in the transfer of study books to DSU (Data Storage Unit) when final QC is complete and update data schedule accordingly.
  • Perform other duties as assigned.
  • The ability to multi-task, coordinate, prioritize, and implement change in combination with flexibility as well as excellent communication and writing skills is a must.
  • Experience with Microsoft Office, word processing spreadsheets (Excel, etc.), and Adobe software.
  • Industry-related pre-clinical data management skills experience preferred.
  • Undergraduate degree in a related life sciences field preferred.
  • Experience with Electronic Data Management System software in a lab setting preferred.
  • Must be computer literate with a willingness to learn and adapt to various computer skills.
  • Must pay attention to detail and constantly question the validity of data.
  • Must be able to lift heavy books and sit and type for long periods of time.
  • Animal facility and laboratories with moderate noise possible and exposure to hazardous/noxious devices (e.g., needles, scalpel blades etc.) and chemicals (e.g., anesthetic gases, formalin, alcohols, xylenes, etc.)
  • General office working conditions, with generally quiet noise conditions

All employees are required to satisfactorily perform the essential duties and responsibilities of their position. • The essential duties and responsibilities listed above are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required. • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

If you are interested in this opportunity please send your CV to