**Local Candidates Preferred**
Job opportunity with a top biopharmaceutical company that is looking for a Sr. Clinical Trial Specialist to join their team on a 12-month contract with a good possibility for conversion or extension!
Requirements and Job Functions:
- BA/BS or higher in nursing, life, or health sciences is preferred. Industry or relevant experience in lieu of education is considered.
- 3 - 5 Years of Experience working for a sponsor pharmaceutical company.
Job Duties:
- Contribute or lead in the creation, updating, or reviewing of study documents including pharmacy manual, Informed Consent forms, study reference materials, subject materials, and clinical study reports.
- Vendor Management. Contribute to vendor evaluation and selection. Hold regular meetings with vendor project managers and oversee day-to-day operations to ensure vendor performance to the statement of work, especially the delivery of critical milestones. Review statements of work and initiate change orders as needed. Verify the accuracy of vendor invoices and monthly accruals. Escalate issues when necessary.
- Clinical Site Management. Oversee multiple clinical sites as sponsor representative, partnering closely with CRO to serve as a resource and confirm site compliance with protocol and escalate to Study Manager as needed. Perform initiation, monitor oversight, and other site visits to assess CRO quality of work and ensure site staff is properly trained and supported. Review trip reports ensuring that clinical sites are receiving adequate monitoring.
- Monitor compliance with GCP, SOPs, and other applicable regulations during the execution of the study. Ensure essential documents from the clinical team, sites, and vendors are maintained in the trial master file.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?