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Study Start Up Specialist

Study Start Up Specialist

EPM ScientificSan Mateo, CA, US
16 hours ago
Job type
  • Full-time
  • Permanent
Job description

Study Start-Up Specialist

Location : San Mateo, CA (Hybrid - 3 days onsite)

Type : Full-Time, Permanent

Compensation : 75,000 - 90,000 annually + bonus + benefits

Are you passionate about clinical research and want to play a key role in bringing innovative therapies to patients?

We are partnered with a sponsor that is seeking a Study Start-Up Specialist to join our dynamic team and support the initiation of clinical trials across North America.

Responsibilities :

  • Identify and evaluate potential research sites through feasibility assessments.
  • Engage with site staff to foster collaboration and ensure readiness for study initiation.
  • Organize and support contract negotiations.
  • Prepare and submit regulatory documents to IRBs and other authorities.
  • Conduct Site Initiation Visits (SIVs) and train site staff on protocols and procedures.
  • Coordinate study supplies and ensure timely delivery.
  • Track and report progress to ensure timely start-up of studies.
  • Communicate effectively with internal teams, vendors, and research sites.
  • Assist with audits, process improvements, and other clinical operations tasks.

Qualifications :

  • Bachelor's degree in Biological Sciences, Nursing, Pharmacy, or related field.
  • Minimum 1 year of experience as a Clinical Research Assistant or similar role.
  • Working knowledge of ICH GCP guidelines.
  • Strong organizational and communication skills.
  • Ability to manage multiple priorities and work in a fast-paced environment.
  • Travel : 20 - 30% travel

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    Specialist • San Mateo, CA, US