Instagram
youtube
Facebook

Clinical Research Associate Ii Or Clinical Research Associate, Germany

2-5 years
Not Disclosed
12 Nov. 24, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Research Associate II (CRA II) / Clinical Research Associate

Overview
The Clinical Research Associate II (CRA II) or Clinical Research Associate ensures the proper conduct, documentation, and reporting of clinical trials at investigative sites or remotely. This role aligns with protocols, SOPs, ICH-GCP guidelines, and regulatory requirements. The focus is on dermatology and rheumatology, offering an opportunity to develop expertise in these therapeutic areas within a mid-sized CRO where contributions are recognized.


Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits per monitoring plans, Innovaderm/Sponsor SOPs, ICH-GCP guidelines, and applicable regulations.
  • Attend investigators’ meetings and represent the company effectively.
  • Prepare detailed site visit reports and follow-up correspondence for investigators.
  • Build productive relationships with investigators and site staff to meet study objectives, including patient recruitment targets.
  • Perform source data verification and ensure compliance with study drug storage, dispensing, accountability, data collection, and regulatory documentation.
  • Adapt to additional responsibilities as assigned, provided the necessary experience, training, and qualifications.

Requirements

Education

  • Bachelor’s degree in a relevant field or nursing degree, or equivalent experience.

Experience

  • 2–5 years of experience as a CRA conducting on-site clinical monitoring within the biotechnology, pharmaceutical, or CRO industries.

Knowledge and Skills

  • Strong understanding of ICH-GCP standards and applicable regulatory requirements.
  • Excellent verbal and written communication skills in English.
  • Proven ability to prioritize assignments, maintain attention to detail, and meet deadlines under pressure.
  • Strong judgment and problem-solving abilities.
  • Willingness to travel to research sites approximately 65% of the time.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint).
  • Dermatology experience is an asset.

Why Innovaderm?

Work Environment and Benefits

  • Permanent full-time position.
  • Flexible scheduling.
  • Home-based, traveling role.
  • Opportunities for continuous learning and professional development.

About Innovaderm

Innovaderm is a renowned Contract Research Organization (CRO) specializing in dermatology. Since its founding in 2000, the company has earned a reputation for delivering exceptional research quality and client services. Based in Montreal, Innovaderm is expanding across North America and Europe.

Commitment to Equity
Innovaderm is dedicated to equitable treatment and equal opportunities. Accommodations are available during recruitment for applicants with disabilities, upon request.

Note: Applicants must have the legal right to work in Germany.


Recruitment Process

The recruitment process includes video interviews with various Innovaderm team members via Teams.

This role provides a dynamic opportunity to contribute to cutting-edge research in dermatology and rheumatology, making a meaningful impact within a collaborative and innovative work environment.