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Clinical Trials Management Associate - II
Ref No.: 18-09766
Location: Foster City, California
Job Title: Clinical Trials Management Associate - II
Duration: 6 months
Location: Foster City, CA- 94404
 
Description:
 
  • Drafts and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports
  • Must be able to understand, interpret and explain protocol requirements to others
  • Maintains study timelines
  • Coordinates review of data listings and preparation of interim/final clinical study reports
  • Assists in determining the activities to support a study’s priorities
  • Contributes to development of RFPs and participates in selection of CROs/vendors
  • May be asked to train CROs, vendors, investigators and study coordinators on study requirements
  • Contributes to development of study budget
  • May contribute to development of abstracts, presentations and manuscripts
  • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision
  • Excellent teamwork, communication, decision-making and organizational skills are required
  • Thorough knowledge of FDA and EMA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
  • Excellent verbal and written communications skills
  • Working knowledge and experience with Word, PowerPoint and Excel
  • Strong problem solving skills
  • May serve as a resource to more junior associates
  • Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams
  • May conduct site evaluation, initiation, co-monitoring, and closeout visits in addition to routine monitoring visits, as required
  • Assures site compliance with the protocol and regulatory requirements
  • Manages vendors
  • Mentors junior team members
  • At least 3+ years of experience and a BS or BA in a relevant scientific discipline
Or
  • At least 3+ years of experience and an RN (2 or 3 year certificate)


Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331