Project Associate

POSITION SUMMARY

The Project Associate (PA) will perform basic project management tasks in the planning, execution, and oversight of single and multi-site clinical trials in ProSciento’s CRO division. The PA will also function as a subject matter expert for the electronic Trial Master File (eTMF) and Clinical Trial Management (CTMS) system.

DUTIES AND RESPONSIBILITIES

• Performs the following study-level start-up activities, including but not limited to;
• Creates the study folder structure in SharePoint
• Sets up the system for the eTMF plan
• Attends all internal, sponsor, and vendor meetings while documenting key decisions and actions
• Performs study-level maintenance activities, including but not limited to;
• Updates the study milestones in Microsoft Project and CTMS
• Maintains data entry in CTMS for applicable fields
• Assists PM with Investigator and Vendor invoice reviews and approvals
• Coordinates the final system and documentation archival process

QUALIFICATIONS/EDUCATION

• Familiarity with Good Clinical Practices (GCP), ICH guidelines and FDA regulations are a bonus.
• Bachelor’s degree in health, biological science, or other related field and 1-year related experience in clinical research or other comparable combination of education, training, and experience.
• Basic knowledge and understanding of CRO clinical systems and procedures.
• Basic knowledge and understanding of applicable regulatory regulations.
• Working knowledge of clinical research; ICF review; IRB submissions; regulatory review/submissions; clinical site oversight; protocol review; and use of clinical systems.