Description
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