Summary
Location
West Coast Division
Type
full-time
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About this role
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 2,800 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 Clinical Research Associate 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 the USA (5 years minimum)
- Experience in all types of monitoring visits in Phase I-III
- Participation in clinical projects as a Senior Monitor
- Experience monitoring complex Oncology trials required; experience with radiopharmaceuticals and/or breast cancer preferred
- Experience monitoring GI studies (IBD, Chron's, UC) is preferred.
- 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 up to 80%
- 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.
For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.
Other facts
About PSI CRO
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
What you'll do
- As a Senior Clinical Research Associate, you will ensure timelines, targets, and standards of clinical research projects while building relationships with clinical sites and investigators. You will also focus on subjects' rights, safety, and quality of data compliance.
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