Clinical Research Associate II, Dermatology & Rheumatology, Germany

Indero; Deutschland; Remote; EUR 50.000 - 80.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Research Associate II specializing in dermatology and rheumatology. In this exciting role, you will monitor clinical studies, ensuring compliance with protocols and regulatory standards while building strong relationships with site staff. This position offers the opportunity to work autonomously in a mid-sized CRO where your contributions are valued. You'll enjoy a flexible, home-based traveling role with ongoing learning and development opportunities. If you're passionate about clinical research and want to make a difference in the field, this role is perfect for you.

Leistungen

Permanent full-time position

Flexible schedule

Home-based traveling position

Ongoing learning and development

Qualifikationen

• 2-5 years of CRA experience in clinical monitoring.
• Strong knowledge of ICH/GCP standards and regulations.

Aufgaben

• Conduct site monitoring visits and ensure compliance with protocols.
• Prepare site visit reports and maintain relationships with investigators.

Kenntnisse

Clinical Research Monitoring

ICH/GCP Standards

Verbal and Written Communication

Problem-Solving Skills

Attention to Detail

Time Management

Microsoft Office

Ausbildung

B.Sc. in a relevant field

Nursing Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Jobbeschreibung

Description

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, 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 II):

• 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

Requirements

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)
• 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
• 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