Job Title: Clinical Trials Management Associate – II
Duration: 6 months
Location: Foster City, CA- 94404
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: (see below) | Phone: 732 272 0331
Foster City, CA, United States of America
$52.55 per hour
Click Apply
NT18-09766
12/21/2018 6:03:06 AM
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