The Clinical Research Associate II (CRA II) 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 (CRAII) :
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
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training
Our company:
The work environment
At Innovaderm, 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.
As a permanent CRA, you will be eligible for the following perks:
Permanent full-time position
Flexible schedule
Home-based traveling position
Ongoing learning and development
Recruitment process: what to expect
As part of the recruitment process for this position you will meet various team members at Innovaderm via Teams video conference
About Innovaderm
Innovaderm is a contract research organization (CRO) specialized in dermatology. 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, Innovaderm continues to grow and expand in North America and Europe.
Innovaderm is committed to providing equitable treatment and equal opportunity to all individuals. As such, Innovaderm will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Innovaderm only accepts applicants who can legally work in Germany
Education
B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
Experience
CRA for 2-5 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)
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