Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Job Description

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.

QualificationsCollege/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!