Sr. Clinical Trial Specialist at PSI CRO

United States

<h3>Company Description</h3><p>PSI is a leading Contract Research Organization with more than 30 years in the industry offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.</p><h3>Job Description</h3><p>The Sr. Clinical Trial Specialist works within the feasibility department in leading research efforts for new business opportunities and data analytic strategies.</p><ul><li> Assesses key study elements that impact investigator interest and patient enrollment</li><li>Reviews scientific literature, industry benchmarking, competition and treatment landscape, epidemiology, PSI historical data, and standards of care</li><li>Develops blinded feasibility questionnaire based on key enrollment drivers and manages the outreach process</li><li>Develops protocol-specific questions for PSI Scientific Advisory Board review</li><li>Completes protocol comparison</li><li>Builds country ranking tables based on key study criteria</li><li>Models enrollment scenarios for dose escalation and expansion studies within PSI Study Modeling tool, VISIONAL</li><li>Develops slides for Bid Defense Meetings (BDM)</li><li>Leads data analytic strategies and integration with CTMS/Site Identification<br/> Module</li><li>Supports local country site outreach efforts for new business opportunities and<br/> awarded studies</li><li>Conducts trainings of PSI staff</li></ul><h3>Qualifications</h3><ul><li>University/college degree in life sciences. Advanced degree in life/biomedical sciences is preferred. </li><li>Minimum 3 years of prior experience in clinical research/medical or scientific research or equivalent.</li><li>Excellent knowledge of reviewing and understanding protocols, ICH GCP, local laws and applicable regulations in the region.</li></ul><h3>Additional Information</h3><p>All your information will be kept confidential according to EEO guidelines.</p>