Description
One of Real Staffing Group's clients is looking for an in-house Sr. CRA with 5 years of site management experience to help work on an urgent project involving site initiation and management.Duties:
- Daily activities will vary depending on the clinical phase of the program. Will have responsibilities for managing more than one project. Determine methods and procedures for performing new assignments. Oversee the activities of CTAs and CRAs.
- Manage contract research organization (CRO) personnel and study sites to ensure studies are completed on time, within budget and in compliance with the protocol, GCPs, FDA regulations and ICH/GCP guidelines, and overall clinical objectives.
- Manage all study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
- Supervise monitoring activities of study data verification on source documentation and case report forms (CRFs) to ensure compliance with the study protocols, GCPs, and SOPs. Ensure data discrepancies are identified and resolved.
- Supervise on-site monitoring visits, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Review site visit reports.
- Supervise activities related to the preparation of all study-related clinical documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
- Participate in the evaluation and selection of sites and CROs, and planning of clinical meetings (investigator meeting, steering committee meeting, CRO kick-off meetings, etc.)
- Broad knowledge of FDA and ICH regulatory requirements.
- Assist in the preparation of study protocols, IBs, and regulatory submissions.
- May represent clinical operations in project team meetings.
- Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Travel is required - up to 25%
- Other duties as assigned.
Requirements:
- B/S
- At least 5 years industry experience
To find out more about Real please visit www.realstaffing.com