Remote Project Support Specialist, Clinical Trials

Pfm

Town of Poland (NY)

On-site

USD 60,000 - 90,000

Full time

14 days+
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Job summary

Precision Medicine Group is seeking a Project Support Specialist to join the project team and help manage timelines, CTMS data, and study materials. The role involves coordinating meetings, maintaining training records, and ensuring access to study sites and sponsors.

Responsibilities include document control, filing, and assisting with IND safety reports and translations as applicable. A 4-year degree and 2+ years in a clinical support role are preferred.

Qualifications

  • 4-year college degree, or equivalent experience in business, science, or healthcare.
  • Minimum of 2 years in Clinical Trial Assistant or similar role.

Responsibilities

  • Create and maintain project timelines in MS Project or similar system.
  • Schedule meetings, prepare agendas, take and distribute minutes, file in Trial Master File.
  • Maintain CTMS data, update milestone dates, enrollment projections and helpdesk tickets.
  • Prepare and document training records, identify gaps and escalate as needed.
  • Set up study SharePoint sites and ensure proper access for team and sponsors.
  • Manage user access requests and review access periodically.
  • Order study supplies, binders, and arrange shipping to locations.
  • Maintain study trackers and help prepare country/site initiation and activation updates.
  • Communicate with sites, investigators and team leaders; assist with SUSARs and distribution of study materials.
  • Support translation, and act as point of contact for project-related requests.

Skills

MS Office
English proficiency
Communication skills
Teamwork
Attention to detail
ICH-GCP knowledge
Regulatory guidance
Interpersonal skills

Education

Bachelor's degree or equivalent

Tools

MS Project
CTMS
SharePoint
Office software suites

Job description

Precision Medicine Group is seeking a Project Support Specialist to join the project team and help manage timelines, CTMS data, and study materials. The role involves coordinating meetings, maintaining training records, and ensuring access to study sites and sponsors.

Responsibilities include document control, filing, and assisting with IND safety reports and translations as applicable. A 4-year degree and 2+ years in a clinical support role are preferred.

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