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SCRA/CRA Germany

Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 
Germany

Offer summary

Qualifications:

B.S./B.A. in health-related or scientific field, Minimum of 5 years in clinical research, Knowledgeable about GCP and FDA regulations.

Key responsabilities:

  • Monitor site activities for clinical trials
  • Review case report forms for data integrity
KPS Life logo
KPS Life Research SME https://kpslife.com/
201 - 500 Employees
About KPS Life
KPS Life is a functional service provider (FSP) that's redefining what "FSP" means. How? By focusing on the one thing that matters above all else: Quality. At KPS, we deliver functional services through a progressive model - one that taps the best clinical ops professionals in the industry, supports them to do their best work, deploys state-of-the-art technologies, and enables full system integration with Sponsors. The result? A flawless model that's raising the bar - and setting a new standard - for clinical operations in pharma and biotech. We guide our clients over any challenge and deliver higher-quality results, which can mean millions of dollars gained and millions of lives saved. KPS by the numbers: > 93% retention rate of CRAs > 8+ years' experience of CRAs > 30% average savings on study costs > 25 countries in which we serve
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Job description

Clinical Research Associate

Summary

Oversees and reviews site activities for clinical trials via on-site monitoring visits and/or in-house assessments according to the trial-specific monitoring plan. Monitors trial records to verify the protection and well-being of study subjects and that reported trial data is adequate, complete, and verifiable from source document data. Reviews site compliance with protocol, Good Clinical Practice (GCP), FDA regulatory requirements, and Standard Operating Procedures (SOPs). Frequent travel to study sites is expected.

Responsibilities

  • Performs pre-study, initiation, interim monitoring, and close-out visits according to applicable SOPs, GCP, and FDA Guidelines.
  • Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data.
  • Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety and well-being, adherence to appropriate safety regulations, and data integrity.
  • Assists with the tracking and reporting of enrollment and works with the site to identify enrollment issues, barriers, and strategies.
  • Responsible for maintaining or gathering site/project-specific information as directed by the sponsor and project management.
  • Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation.

Minimum Requirements

  • B.S./B.A. in a health-related or scientific field and a minimum of 5 years of experience in clinical research, or an equivalent combination of education and experience.
  • Knowledgeable about relevant GCP and FDA regulations as they relate to clinical trial compliance.
  • Ability to travel

#kpslife

Required profile

Experience

Level of experience: Senior (5-10 years)
Industry :
Research
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Website MonitoringFDA RegulationsClinical ResearchGood Clinical Practices (GCP)Safety StandardsData IntegrityCase Report FormsRegulatory Documents

Other Skills

  • Time Management
  • Teamwork
  • Communication
  • Problem Solving
Are you interested?

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