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- Aufgaben: Monitor clinical studies, ensuring compliance with protocols and regulations.
- Arbeitgeber: Innovaderm is a leading CRO specializing in dermatology with a strong reputation for quality.
- Mitarbeitervorteile: Enjoy a permanent full-time position with remote work options and ongoing learning opportunities.
- Warum dieser Job: Join a collaborative team where your contributions are valued and make an impact in dermatology.
- Gewünschte Qualifikationen: B.Sc. in a relevant field and 2-5 years of CRA experience required.
- Andere Informationen: Travel to research sites approximately 65% of the time; must be eligible to work in Germany.
Das voraussichtliche Gehalt liegt zwischen 43200 - 72000 € pro Jahr.
Clinical Research Associate II, Dermatology & Rheumatology, Germany
About The Position
Clinical Research Associate II, Dermatology & Rheumatology, Germany
The Clinical Research Associate II (CRA II) will monitor the progress of clinical studies at investigative sites or remotely, ensuring 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 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 II):
- Conducts site qualification, initiation, monitoring, and close-out visits for research sites according to the monitoring plan, Innovaderm and sponsor SOPs, ICH/GCP 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.
- May be assigned other responsibilities that do not pertain to their former description, if they have the required experience, are qualified, and/or have received adequate training.
Requirements
Education
- B.Sc. in a field relevant to clinical research, nursing degree, and/or equivalent experience.
Experience
- 2-5 years of experience as a CRA 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 judgment 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 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.
- 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.
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Clinical Research Associate II, Dermatology & Rheumatology, Germany Arbeitgeber: Innovaderm Research
Kontaktperson:
Innovaderm Research HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Clinical Research Associate II, Dermatology & Rheumatology, Germany
✨Tip Number 1
Familiarize yourself with the specific ICH-GCP guidelines and regulatory requirements relevant to dermatology and rheumatology. This knowledge will not only help you during the interview but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the dermatology and rheumatology sectors. Attend industry conferences or webinars to connect with potential colleagues and learn more about current trends and challenges in clinical research.
✨Tip Number 3
Prepare to discuss your previous experiences in clinical monitoring, especially any specific challenges you faced and how you overcame them. Highlighting your problem-solving skills will be crucial for this role.
✨Tip Number 4
Since this position involves significant travel, be ready to talk about your flexibility and experience managing multiple site visits. Share examples of how you've successfully prioritized tasks under pressure.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Clinical Research Associate II, Dermatology & Rheumatology, Germany
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Clinical Research Associate II position. Tailor your application to highlight your relevant experience in clinical monitoring, especially in dermatology and rheumatology.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 2-5 years of experience as a CRA, focusing on your ability to conduct site visits, monitor compliance with ICH-GCP standards, and manage relationships with investigators and site staff.
Showcase Communication Skills: Since strong verbal and written communication skills are essential for this role, provide examples in your application that demonstrate your proficiency in English and your ability to prepare clear reports and correspondence.
Prepare for the Interview: If selected for an interview, be ready to discuss your problem-solving skills and how you prioritize tasks under pressure. Familiarize yourself with Innovaderm's values and be prepared to explain how you align with their collaborative and innovative work environment.
Wie du dich auf ein Vorstellungsgespräch bei Innovaderm Research vorbereitest
✨Know Your ICH/GCP Standards
Make sure you have a solid understanding of ICH/GCP standards and applicable regulatory requirements. Be prepared to discuss how you've applied these in your previous roles, as this will demonstrate your expertise and readiness for the CRA II position.
✨Showcase Your Experience
Highlight your 2-5 years of experience as a CRA, especially any specific projects related to dermatology or rheumatology. Use concrete examples to illustrate your ability to work autonomously and meet quality standards under pressure.
✨Prepare for Behavioral Questions
Expect questions that assess your problem-solving skills and judgment. Prepare examples from your past experiences where you successfully navigated challenges in clinical monitoring or built productive relationships with site staff.
✨Demonstrate Communication Skills
Since strong verbal and written communication skills are crucial for this role, practice articulating your thoughts clearly. You might be asked to explain complex concepts or report findings, so being concise and clear is key.
