As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
Responsibilities
-Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits.
-Act as the main line of communication between project team, Sponsor and the site.
-Ensure that subject recruitment targets and project timelines are met at site level.
-Perform CRF review, source document verification, drug accountability, and query resolution.
-Facilitate the flow of site documents, assist in maintaining study-specific and corporate tracking systems.
-Support Study Startup and Regulatory teams in preparation of draft regulatory and ethics committee submission packages .
-Conduct project-specific training of Investigators, prepare Investigator newsletters.
-Participate in study site audits and client onsite visits, as required.
-Monitor project timelines and patient enrollment, implements respective corrective and preventive measures.
-Support junior Monitors in the query resolution process, including Central Monitoring observation.
-Coordinate safety information flow and protocol/process deviation reporting
-Perform clinical supplies management with vendors.
-Support site contracting and payments.
-May lead project team calls on a country level.
Qualifications
-College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
-Substantial independent on-site monitoring experience
-Experience in all types of monitoring visits in Phase II and/or III
-Experience in feasibility assessment and study set-up process is preferable
-Experience in Oncology therapeutic indications is a plus (preferable)
-Full working proficiency in English
-PC skills to be able to work with MS Word, Excel and PowerPoint
Ability to plan, multitask and work in a dynamic team environment
-Communication, collaboration, and problem-solving skills
-Ability to travel
Additional Information
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company, that puts its people first!