Clinical Trial Associate

In your role as a Clinical Trial Associate, you will assist the Project Managers and Project Coordinators providing administration and project tracking support to ensure most effective and efficient conduct of clinical research at start-up, execution, and closeout stage of the project. You will play a key role in the coordination and organization of materials for Phase 1-4 clinical trials.

You will also provide support to the Data Monitoring Committee (DMC) Project Coordinators in the organization, contracting and follow-up of DMC meetings.

You will work alongside a team of highly skilled clinical trialists and researchers as part of the Project and Document Management team, and will report directly to the Director, Project and Document Management. To help you thrive in your role and develop further your career, you will receive the necessary trainings, mentoring and coaching from your peers.

This is a temporary 6-month contract with the possibility of extension based on business needs.

In addition, your responsibilities will be to:

• Work together with the Project Managers and Project Coordinators to ensure that key project information related to project milestones, team members, training records and electronic Trial Master File is up to date
• Initiate and coordinate archiving of studies in the eTMF per IDDI SOPs
• Support IDDI Project Managers in preparing study trackers and following up on study meeting and planning
• Provide support to Project Coordinators in the organization, contracting, and follow-up of IDMC meetings for studies in which IDDI is serving as the unblinded independent statistical group coordinating and reporting to the committee.
• Represent IDDI as a point of contact for clients and collaborators, including providing liaison support between the Independent Statistician, study Sponsor personnel, and members of IDMCs while carefully maintaining study blinding/masking and trial integrity (e.g., scheduling meetings, hosting videoconferences, troubleshooting access to reports)
• Perform Data Monitoring Committee (DMC) tasks:
  • Schedule DMC meeting at the request of the DMC independent statistician
  • Proactively go back to client or DMC members if difficulties in finding a slot
  • Organize TC/WebEx for DMC meetings
  • Coordinate with Relish the face-to-face meetings
  • Print DMC reports
  • Check with DMC members if they successfully accessed the closed report on the Vault
  • Follow and process DMC members’ invoices
  • Prepare and keep DMC overview document and transition documents up-to-date
  • Keep team lists and DMC member lists up-to-date

The successful candidate must have a Bachelor’s degree in life sciences or health-related field, or at least 2 years of relevant clinical trials experience. In addition, the position requires:

• Knowledge and experience with Good Clinical Practice (GCP) regulations and clinical trial processes
• Experience with electronic Trial Master Files (eTMF) and archiving a plus
• Familiar with Structure and Essential Documents per ICH and GCP guidelines
• Experience with Veeva Vault software
• Weekly office presence
• Demonstrated ability to manage multiple tasks simultaneously and complete work within allocated time frames
• Proactive, reactive and ability to work independently
• Methodical, logical, detail and quality oriented
• Organized with excellent administrative skills
• Ability to solve problems and to motivate others
• Excellent English with good communication skills, both oral and written
• Good working knowledge of Microsoft Word and Excel
• Good time management skills
• High attention to details
• Strong interpersonal and communication skills, with ability to utilize diplomacy under pressure when troubleshooting issues and scheduling with collaborators such as investigators, researchers, and senior study management