Senior Clinical Research Associate

PSI CRO; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

PSI CRO is seeking a Senior Clinical Research Associate in the United States to lead onsite monitoring and site management across diverse therapeutic areas. You will collaborate with project teams to ensure patient safety, data quality, and regulatory compliance.

You will build strong relationships with sites, perform source verification, support feasibility studies, and assist in study submissions. A Life Sciences degree and 5+ years of on-site monitoring experience in the USA are required.

Qualifications

• College/University degree in Life Sciences or equivalent.
• Independent on-site monitoring experience in the USA (5 years minimum).
• Experience in Phase I-III monitoring visits.
• Participation in clinical projects as a Senior Monitor.
• Oncology trials experience; radiopharmaceuticals/breast cancer preferred.
• GI studies experience preferred (IBD, Chron's, UC).
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Strong communication, collaboration and problem-solving skills.
• Ability to travel up to 80%.
• Valid driver’s license (if applicable).

Responsibilities

• Conduct and report all types of onsite monitoring visits.
• Involve 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 at the country level.
• Be a point of contact for in-house support services and vendors.
• Involved in quality control, such as compliance monitoring and reports review.
• Participate in feasibility research.
• Support regulatory team in preparing documents for study submissions.

Skills

Independent on-site monitoring

Travel up to 80%

Communication problem-solving

English proficiency

MS Office proficiency

Team-oriented planning

Education

Life Sciences degree

Tools

MS Office

Job 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.

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.

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

• 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 Oncologytrials 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)

For this position PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Advance your career in clinical research and lead challenging full-service projects on the country/regional levelwhile growing with a rapidcompany, 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.