Offer summary

Qualifications:

College/University degree in Life Sciences or equivalent education and experience., Minimum of 5 years independent on-site monitoring experience in the USA., Experience in monitoring Phase II and/or III clinical trials, particularly in complex Oncology trials., Proficiency in English and MS Office applications, with strong communication and problem-solving skills..

Key responsibilities:

Conduct and report onsite monitoring visits and manage site communication.

Supervise study activities, timelines, and schedules at the country level.

Participate in quality control and compliance monitoring activities.

Support the regulatory team in preparing documents for study submissions.

Job description

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 2,000 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 you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.

Office-Based or Home-based

You will:

Conduct and report all types of onsite monitoring visits
Be involved in study startup (if applicable)
Perform CRF review, source document verification and query resolution
Be responsible for site communication and management
Supervise study activities, timelines, and schedules on the country level
Be a point of contact for in-house support services and vendors
Be involved in quality control, such as compliance monitoring and reports review
Participate in feasibility research
Support regulatory team in preparing documents for study submissions

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training & experience
Independent on-site monitoring experience in USA (5 years minimum)
Experience in all types of monitoring visits in Phase II and/or III
Participation in clinical projects as a Lead/Senior Monitor
Experience monitoring complex Oncology (breast cancer) trials required
Full working proficiency in English
Proficiency in MS Office applications
Ability to plan, multitask and work in a dynamic team environment
Communication, collaboration, and problem-solving skills
Ability to travel
Valid driver’s license (if applicable)

Additional Information

Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.

Required profile