Clinical Project Specialist, Study Operations (12-Month Contract)

GForce Life Sciences

Fort Snelling Unorganized Territory (MN)

On-site

USD 70,000 - 90,000

Full time

9 days ago

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Benefits offered by this job

Medical
Dental
Vision
401k

Job summary

GForce Life Sciences is assisting a Fortune 500 Medical Device Company to fill an entry-level Consultant, Clinical Project Specialist role in the Study Operations Project Management team. You will participate in the execution of clinical device studies, ensure compliance with protocol, GCP, and regulatory standards, and support study management activities including vendor oversight.

The role supports site investigators and clinical staff, requires a Bachelor’s degree and at least 3 years in

Qualifications

  • Bachelor's degree required; natural science/pre-medicine/nursing/bioengineering or related field preferred.
  • Minimum 3 years in clinical operations or healthcare-related field.
  • Strong written and verbal communication, interpersonal, analytical and organizational skills.

Responsibilities

  • Manage all aspects of the subject selection committee work.
  • Track data entry needs and timelines to sites, core labs, and colleagues.
  • Apply protocol and charter requirements to resolve discrepancies before committee review.
  • Facilitate adjudications via offline email review and live teleconference calls.
  • Process images with sites/core labs and assist in slide preparation for reviews.
  • Communicate review status and final adjudication results to investigators and staff.
  • Track consultant billing and committee member consulting time.
  • Document committee decisions promptly and archive supporting documentation.
  • Collaborate with study and field teams to track prospective committee cases.
  • Provide feedback for study protocol sections, training, and presentations.
  • Manage trial timelines and deliverables for annual database locks.

Skills

Communication
Analytical
Organizational skills
Problem-solving

Education

Bachelor's degree in natural science or related field

Job description

GForce Life Sciences is assisting a Fortune 500 Medical Device Company to fill an entry-level Consultant, Clinical Project Specialist role in the Study Operations Project Management team. You will participate in the execution of clinical device studies, ensure compliance with protocol, GCP, and regulatory standards, and support study management activities including vendor oversight.

The role supports site investigators and clinical staff, requires a Bachelor’s degree and at least 3 years in

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