Senior Clinical Research Associate, Dermatology & Rheumatology (Germany)
The senior clinical research associate (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 senior 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 regulationsParticipates in investigators’ meetingsPrepares site visit reports and follow-up letters to the investigatorBuilds productive relationships with investigators and site staff to achieve study objectives, including patient recruitment targetsPerforms source data verification, ensures on-site study drug storage, dispensing, and accountability, data collection, and regulatory document collection is adequateThe Sr CRA may also assume the following Lead CRA 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.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.
Work location
Note that this opening is for a home-based position in Germany
Regular travel, which may include overnight trips and / or international travel is required as part of this role.
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 experienceExperience
At least 5 years experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and / or contract research organization (CRO) industryKnowledge and skills
Good knowledge of ICH / GCP standards and applicable regulatory requirementsStrong verbal and written communication skills in EnglishAbility to prioritize different assignments and work under pressure while maintaining attention to detail and meeting timelinesExcellent judgement and problem-solving skillsTravel to research sites approximately 65% of the timeExcellent knowledge of Microsoft Office (i.e., Word, Excel, PowerPoint)Experience in dermatology is an asset