Clinical Site Manager / Sr. CRA

Job type:
on-site
Start:
01/2012
Duration:
12 months
From:
Real Staffing
Place:
South San Francisco
Date:
12/12/2012
Country:
flag_no USA
project ID:
460182

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
DUTIES AND JOB RESPONSIBILITIES:
  • Work with the Clinical Project Manager to coordinate activities of multiple vendors leading to site activation according to timelines.
  • Assist in setting study timelines.
  • Review protocols, electronic case report forms, monitoring plans (may generate as necessary), and site visit reports (as necessary), data listings, and clinical study report (as necessary).
  • Generate ICFs and manage the review and approval process.
  • Develop study documents and tools, as needed (e.g. Study Log and Source Document Worksheets Review and approve content of Study Binders (Investigator Site File and Site Reference Manual).
  • Order study supplies as necessary.
  • Monitor essential document collection to ensure it meets quality standards as set by the company.
  • Assure site monitoring and compliance within routine protocol and regulatory requirements to ensure high-level quality of data. Review and manage resolution (including implementation of corrective action plans) of site and monitoring issues/deviations.
  • Review and approve site visit plans and monitor to ensure visits are conducted according to plan.
  • Manage protocol exemption process (as necessary); working with the Medical Monitor
  • Review routine data and preparation of safety interim and final study reports and resolution of data discrepancies.
  • Assist in training CRAs and CTAs as necessary.
  • May manage service providers as necessary for given area(s) of clinical operations of a study.
  • 15% -20% Travel is required (e.g. face to face meetings with service providers, site visits if deemed necessary).

QUALIFICATIONS AND REQUIREMENTS:
  • Thorough knowledge of site activation and clinical monitoring procedures
  • Able to work within a team
  • Strong computer skills (MS Office, Excel)
  • Strong working knowledge of FDA & ICH/GCP regulations and guidelines
  • Strong analytical and assessment skills
  • Strong judgment and problem solving skills
  • Strong communication (in all media) skills

EDUCATION AND EXPERIENCE:
  • Bachelor's degree in a relevant scientific discipline or equivalent
  • 2-4 Years of Industry experience in Clinical Operations
  • Lead CRA in a sponsor company (1 Year) preferred
  • At Least 1 year Vendor(s) Management Preferred
  • Phase II experience with multi-center of at least 10 sites preferred
  • Therapeutic area (Immunology preferred)
  • Co- Monitoring experience preferred


To find out more about Real Staffing please visit www.realstaffing.com