Sara Benolkin's Email & Phone Number

💼 Past Experience

Director, Clinical Operations (DCO) at PRA Health Sciences- Jul 2019 - present - Leads Clinical Dedicated Operational Center (CDOC) with oversight of all clinical team roles to ensure successful delivery of clinical projects and consistency with global partners and client portfolios - Ensures appropriate clinical team resourcing across the Americas for Clinical Team Managers (CTMs), Clinical Research Associates (CRAs) and Central Monitoring Associates (CMAs), including decision making for headcount projections, interviewing and hiring of Clinical Team Managers and Directors and Managers of Clinical Operations - led collaboration with Early Development Services (EDS) and Real World/Late Phase Services (RWS) to ensure Phase I to Phase IV consistency and seamless transitions for program pipelines- responsible for training and development of teams to ensure optimal performance, compliance with PRA systems and processes and career development, including collaboration with HR Business Partners - responsible for oversight of quality clinical project deliverables within contracted time and cost Reviews status of clinical studies and deliverables with focus on patient safety, risk, quality and financial management -Managed project risks and supports the development of mitigation strategies and effective escalation to executive leadership - Globally collaborates with leadership in project management, data management and medical/therapeutic expertise to ensure holistic health of projects and teams - provides leadership as a Portfolio oversight expert for specific clients, therapeutic areas and programs - member of Clinical Quality Initiative Leadership Committee and represents Clinical Operations on the Adaptive/Risk-Based Monitoring and Innovation Leadership Committee - served as company and industry representative to TransCelerate initiative for setting guidelines for eConsent in 2016 - won the PharmaTimes Clinical Researcher of the Year Award in 2017 (Silver, Company: Gold) - manager, Clinical Operations (MCO) at PRA Health Sciences from October 2011 to February 2016 (4 years 5 months)- senior MCO: Jul 2015- Feb 2016- assessed clinical operations employee resources and employee resource projections to ensure that project teams meet client expectations and PRA contractual obligations- scheduled and reviewed project tasks, provided leadership in the delivery of services to clients, including client-facing program alignment - Ensure staff fulfill their responsibilities in accordance with PRA’s policies, procedures, FDA CFR, ICH-GCPs, and country and/or ethics committee specific regulatory requirements - Recommended and implemented clinical operations performance and productivity improvements to optimize utilization of staff and to optimize employee performance and retention- participated in PRA’s quality efforts for continuous improvement by assuring quality metrics are in line with company, client and clinical operations objectives -senior clinical research associate (CRA) at PRA Health Sciences from January 2006 to November 2006 (11 months)- implemented and monitored clinical trials to ensure sponsor and investigator obligations were met and compliant with applicable local regulatory requirements and ICH guidelines - visited sites to assess the qualification of potential investigative sites, initiated studies, instructed site personnel, ensured accuracy of data collected and terminated studies- provided regular clinical status information to team members and project management- worked.

🎓 Education

Sara Benolkin's education and current work readiness are based on her education and past work experience in the medical field. Sara Benolkin earned her BA from Texas A&M University in 1997, her BS from Baylor University in 1995. She has experience as a pre-med major at Texas A&M University from 1997 to 1999, and as a pre-med minor at Baylor University from 1995 to 1997. Sara Benolkin has experience in the medical field as a staff member at a hospital where she worked as a medical resident from 2001 to 2003. From 2004 to 2006, she was a Medical Officer in Charge at a healthcare system in Dallas, Texas. Sara Benolkin has experience in the medical field in substantial work capacity as Medical Officer in Charge at a healthcare system from 2006 to present.Sara Benolkin is a staff member at Medical Officer in Charge at a healthcare system from 2006 to present. Sara Benolkin has significant work experience in the medical field in a substantial work capacity as Medical Officer in Charge at a healthcare system from 2006 to present.Sara Benolkin has a background in biology and an interest in environment and public health. Sara Benolkin is training to become a medical doctor. Her education and current work readiness are based on her own education and past work experience in the medical field.

💡 Technical & Interpersonal Skills

Sara Benolkin has 4 years of experience as a Director of Clinical Operations at PRA Health Sciences. Her duties include managing Clinical Operations and providing leadership for clinical projects. SaraBenolkin has experience in the design, execution, and quality of clinical projects. In her previous roles, she was responsible for training and development of teams, ensuring that projects meet client expectations and PRA contractual obligations, and ensuring staff fulfill their responsibilities in accordance with PRA policies, procedures, and FDA CFR. SaraBenolkin has worked with an international team of clinical researchers, project managers, and quality assurance inspectors. She has also developed contingency and mitigation plans in case of project disruptions.