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.

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.

• 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.

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!