Clinical Research Associate II (Contract based)

Psi CRO; Porto; Híbrido; EUR 34 000 - 69 000; Tempo parcial

Resumo da oferta

Psi CRO in Portugal is seeking a Contract Clinical Research Associate II to monitor Phase II/III trials, ensuring patient safety, data quality, and adherence to timelines and regulatory standards.

This is a home-based (freelance) role. You will conduct onsite monitoring visits, assist in study startup, review CRFs, resolve queries, manage site communications, and support regulatory submissions. Fluent English and Portuguese are required; travel may be needed.

Qualificações

• Life sciences degree or equivalent.
• At least 1 year of independent on-site monitoring in Portugal.
• Experience in Phase II/III monitoring.
• Experience with IBD is mandatory.
• Fluent in English and Portuguese.
• Proficiency with MS Office tools.
• Strong planning, multitasking and team collaboration skills.
• Willingness to travel.

Responsabilidades

• Conduct and report on-site monitoring visits.
• Involvement in study startup activities.
• Perform CRF review, source data verification and query resolution.
• Manage site communication and oversight.
• Supervise study activities and timelines at country level.
• Coordinate with in-house teams and vendors.
• Contribute to quality control and regulatory submissions.
• Assist feasibility research.

Conhecimentos

Fluent English

Fluent Portuguese

Communication

Teamwork

Formação académica

Life Sciences degree

Ferramentas

MS Office

Descrição da oferta de emprego

Clinical Research Associate II (Contract based)

• Contract

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

As a Contract Clinical Research Associate II, 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.

Home-based (freelance)

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup
• 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
• A minimum of 1 yearof independent on-site monitoring experience in Portugal
• Experience in all types of monitoring visits in Phase II and/or III
• Experience in IBD/Inflammatory Bowel Diseases is mandatory
• Full working proficiency in English and Portuguese
• 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

Make the right call andtake your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.