Clinical Research Associate II, Dermatology & Rheumatology CRO, Poland

Clinical Research Associate II, Dermatology & Rheumatology, Poland, Canada

The clinical research associate II (CRA) will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

This role will be perfect for you if:

• You are a seasoned Clinical Research Associate (CRA) who thrives in autonomous environments and consistently meets high-quality standards and deadlines.
• You bring experience in dermatology and rheumatology, and you're eager to deepen your expertise in these therapeutic areas.
• You value working within a mid-sized CRO where your contributions are visible, appreciated, and have a direct impact.

RESPONSIBILITIES

The clinical research associate II (CRA):

• Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/CGP guidelines and applicable regulations
• Participates in investigators’ meetings
• Prepares site visit reports and follow-up letters to the investigator
• Builds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targets
• Performs source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequate

The CRA II responsibilities:

• Reviews and approves site visit reports.
• Tracks site visit and trip report metrics and escalates issues to project teams.
• Recommends potential solutions to identified issues and work with the project managers to find resolution.
• Supports the development of annotated site visit reports, clinical monitoring plans, and monitoring tools.
• Supports the preparation and development of materials related to the training of CRAs.
• Mentors CRAs.
• Conducts on-site quality control visits with CRAs.

Requirements:

Education

• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience

Experience

• 2 to 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
• Dermatology and/or Rheumatology exposure

Knowledge and skills

• Good knowledge of ICH/GCP standards and applicable regulatory requirements
• Strong verbal and written communication skills in English
• Ability to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelines
• Excellent judgement and problem-solving skills
• Travel to research sites approximately 65% of the time
• Excellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)
• Experience in dermatology

Brand name:

Indero

Our company:

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:

• Permanent full-time position
• Vacation, PPK, health allowance
• Home-based position with teleworking allowance
• Ongoing learning and development

Work location

This position is opened to candidates across Poland (home-based position).

About Indero

Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Poland.