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!
Remote Work :
No
Employment Type :
Full-time