Site Management Associate (Clinical Research)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
TL;DR
Site Management Associate (Clinical Research): Supporting and managing clinical trial sites through start-up, conduct, and closeout activities with an accent on regulatory compliance and investigator relationships. Focus on coordinating site initiation timelines, managing essential documentation, and ensuring adherence to GCP and study protocols.
Location: Remote (US) or Morrisville, North Carolina
Company
partners with sponsors to provide patients and physicians early access to medicines when no other treatment options are available.
What you will do
- Collaborate with Clinical Operations to develop site initiation timelines and ensure adherence to project milestones.
- Prepare and manage site startup documentation, including contracts, informed consent forms, and regulatory submissions.
- Coordinate with contracts and budget teams to ensure timely execution of site agreements.
- Verify site readiness, including resource availability and completed training prior to patient enrolment.
- Ensure all documents are approved by ethics committees and IRBs before site activation.
- Troubleshoot activation issues and escalate problems to the Project Manager or CRA.
Requirements
- Bachelor's Degree (health or science field preferred).
- 2+ years’ experience in site management, clinical research, or equivalent.
- Proficiency in Microsoft Office and clinical systems (e.g., EDC, CTMS, eTMF).
- Effective verbal and written communication skills.
- Ability and willingness to travel up to 20% of the time.
Culture & Benefits
- Comprehensive medical, dental, and vision insurance, including FSA and HSA.
- 401K safe harbor plan with company match.
- Paid vacation, holiday, and sick time.
- Paid maternity and paternity leave.
- Voluntary short-term and long-term disability and life insurance.
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