A leading Global Pharmaceutical client is seeking to hire a contract Senior Clinical Trial Associate to join them on a 1 year contract.
Title: Senior Clinical Trial Associate
Duration: 12 Month
Location: On site- Summit, NJ
Hours expected: 40 hours per week
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Day to Day Duties/Responsibilities/ Scope of Work
- Support the Study Team to select potential investigators and assess their interest in the study
- Communicate with the sites through direct contact and other tools such as newsletters as appropriate per study requirements
- Track study progress in CTMS including patient enrollment and patient status
- Oversight of Monitoring Visit Report review for CROs
- Support study data as the EDC administrator and by tracking CRFs and queries as appropriate for insourced studies
- Process and track payments to vendors and study sites as appropriate
- QC review of ICFs returned from the sites.
- Investigational Product reconciliation.
- Financial Reconciliation at the close of studies
- Support the Study Manager in creating, updating and tracking MS Project study plans Collecting, quality review and submitting documents to the TMF
- Performing quarterly QC of TMF as appropriate
- Support planning and logistics for meetings including investigator meetings, study team meetings, and meetings with CROs and other vendors Generate, finalize and distribute study team agendas and meeting minutes
- Assist with generating the CSR appendices and participate in SOP and WP development Mentor and coach other CTAs, as appropriate, and participate or provide leadership in departmental initiatives
- BS degree in biomedical science (Masters preferred) with 10+ years in the pharmaceutical industry or in a CRO
3+ years experience as a CTA in pharmaceutical, CRO, or healthcare environment.
Sthree US is acting as an Employment Business in relation to this vacancy.