Senior Clinical Research Associate / Clinical Research Associate II

Description

Senior Clinical Research Associate / Clinical Research Associate II, Poland (dermatology and rheumatology CRO)



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 an experienced CRA with a demonstrated ability to work autonomously to meet quality standards and deadlines
• Focusing on dermatology and developing an expertise in this therapeutic area is interesting to you
• You enjoy working for a mid-sized CRO where your contributions are noticed and valued

RESPONSIBILITIES 

The clinical research associate (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

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

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 is an asset

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).

Recruitment process: what to expect

• As part of the recruitment process for this position you will meet various team members at Indero
• The first interview will be conducted by Teams (20 minutes) and the second via video conference ( Teams 1 hour)

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.