Clinical Research Associate II

South San Francisco  ‐ Onsite
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Keywords

Description

Job Description:
  • Performs clinical study or clinical site feasibility
  • Assist in the activities associated with site start-up and management
  • Support the administration of study budgets
  • Coordinate the preparation and conduct Investigator Meetings
  • Monitor progress of studies identifying delays and initiating corrective actions when necessary
  • Track study related trends
  • Support CRO relationships
  • Monitor clinical sites for adherence to protocol, GCP and company SOPs
  • Ensures quality of data generated from clinical sites and assists in resolving patient eligibility and protocol deviation issues
  • Ensures adverse events are reported properly and follow-up in a timely manner
  • Assist with operational activities associated with clinical studies. This may include communicating with sites, various CROs and vendors involved in the studies.
  • Review regulatory documents, track in database and file in the clinical master files
  • Contribute to the administrative details of the following materials for clinical trial conduct: informed consent forms, study instructions, case report forms (CRFs) clinical trial binders, subject status tracking etc.
  • Assist with study drug requests
  • Assist in the management of clinical drug supplies, provide detailed reports to ensure sites have adequate clinical supplies to enroll patients without excessive waste of clinical products
  • Develop newsletters and other patient recruitment tools to help motivate investigators to achieve target enrollment
  • Assist in the administrative preparation of protocols, amendments, investigational brochures, CRFs and other study-specific documents
  • Assist in the organization and preparation for investigator, expert, IDMC and other meetings
  • Assist in the tracking and administration of study budgets
  • Assist in the preparation of progress updates


Requirements:
  • Candidate will have a BA or BS in the sciences field.
  • 3-4 years working in the industry is required, and at least one year of monitoring experience.
  • Candidate will have strong written and verbal communication skills, and good organization skills with an attention to detail.
  • The ability to work independently and collaboratively to provide high quality work while prioritizing task and meeting timelines.
  • This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.
  • Up to 25% travel may be required.
  • Experience in the oncology therapeutic area is desirable.


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
From
Real Staffing
Published at
13.04.2014
Project ID:
694901
Contract type
Freelance
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