Senior Clinical Research Associate

PSI CRO·Remote, US, United States

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About the role

Remote Senior Clinical Research Associate role supporting clinical research projects across therapeutic indications. Responsibilities include onsite monitoring, study startup, CRF review, source document verification, query resolution, site management, country-level supervision, quality control, feasibility research, and regulatory submission support. A Life Sciences degree or equivalent education, training, and experience is required, along with at least five years of independent US on-site monitoring experience and complex oncology trial monitoring.

Key requirements

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• At least 5 years of relevant experience
• Required skills: Independent on-site monitoring experience in the USA, Experience in all types of monitoring visits in Phase I-III, Participation in clinical projects as a Senior Monitor, Complex oncology trial monitoring, Clinical site and investigator relationship management, CRF review, Source document verification, Query resolution, Site communication and management, Study activity, timeline, and schedule supervision, Quality control and compliance monitoring, Feasibility research, Regulatory submission support, MS Office applications, Planning, multitasking, and teamwork, Communication, collaboration, and problem-solving, Ability to travel up to 80%
• Required language: English
• Professional registration/licence (United States)
• Work authorization for United States may be required

Opportunity details

Employer’s role description

Job title: Senior Clinical Research Associate

Location: Remote, US, United States

Employment type: Full-time

Workplace type: Remote

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 3,000 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 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

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)

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

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.