Senior Clinical Research Associate

PSI CRO • Remote, US

4d • Onsite

About The Position

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. You will be responsible for site communication and management, supervise study activities, timelines, and schedules on the country level, and act as a point of contact for in-house support services and vendors. You will also be involved in quality control, such as compliance monitoring and reports review, participate in feasibility research, and support the regulatory team in preparing documents for study submissions.

Requirements

• 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
• 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)
• PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Nice To Haves

• experience with radiopharmaceuticals and/or breast cancer preferred
• Experience monitoring GI studies (IBD, Chron's, UC) is preferred.

Responsibilities

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree