Clinical Research Associate I

PSI CRO; United States; On-site; USD 65,000 - 95,000; Full time

Job summary

PSI CRO is seeking a Clinical Research Associate to join our trials team in the United States. You will conduct onsite monitoring visits, maintain robust site relationships, and support regulatory submissions to ensure data integrity and patient safety throughout studies.

You will coordinate with project teams, perform CRF reviews, and assist in study startup activities while traveling to sites as required. A life sciences background and English fluency are essential for success.

Qualifications

• College/University degree in Life Sciences or equivalent required.
• Experience as Study Coordinator (or similar) required.
• Gastroenterology trials experience preferred.
• Full working proficiency in English.
• Willingness to travel frequently and hold a valid driver's license.

Responsibilities

• Conduct onsite monitoring visits and report outcomes.
• Be involved in study startup activities where applicable.
• Perform CRF review, source document verification and query resolution.
• Manage site communications and relationship with investigators.
• Act as a liaison for in-house support services and vendors.
• Communicate study progress with internal project teams.
• Participate in feasibility research.
• Assist regulatory team in preparing study submission documents.

Skills

Study coordination experience

English proficiency

Multitasking

Communication skills

Team collaboration

Travel willingness

Driver's license

Education

Life Sciences degree or equivalent

Tools

MS Word

MS Excel

MS PowerPoint

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 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

As a 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
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• 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
• Experience as a Study Coordinator (or similar role)is required
• Experience working onGastroenterology clinical trialspreferred
• 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 and willingness to travel frequently
• Valid driver’s license

Become a full-fledged clinical research professional with the support of a knowledgeable and professional team. You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.

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