(Senior) Clinical Research Associate

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Irfa******

  • United States 
  • Last Update: 24.12.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
1 Month +
Place
Berlin, DE
Country
United States

Category


Clinical and medical development

Description


Summary

If you are seeking a career where you can truly make a difference in the lives of others, working closely together with the top minds in Biotechnology, then here is your chance. DOCS is hiring several Clinical Research Associate's (m/w) of all experience levels to work closely with one of the most successful pharmaceutical companies. If you are a CRA anywhere in Germany willing to work home based and open for a new challenge, we would like to get to know you.

Key Responsibilities
  • Ensures clinical study sites are conducting clinical trials in compliance with the respective protocol, SOPs and applicable ICH/GCP guidelines and regulations
  • Provide input into feasibility, identify clinical investigators and conducts site evaluations post-feasibility to determine site suitability and selection
  • Conduct Investigator Profile and Clinical Site Initiation visits as well as Clinical Site Close-Out visits
  • Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
  • Identify site needs and site-related issues, escalate them and/or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process
  • Ensures appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs)
  • Facilitate the resolutions of clinical queries to investigative staff in accordance to the study specific monitoring plan
  • Report Important Protocol Deviations (IPDs) and develop issue resolution plans
  • Review, collect and maintain essential documents, submit to CTA for processing
  • Develop site visit plans and conduct monitoring visits
  • Prepare reports for Investigator and Site Evaluations, Clinical Site Initiation, Clinical Site Monitoring, and Clinical Site Close-Out
  • Assist in preparing sites for audits, review audit reports and contributes to resolve findings
  • Build and maintain solid and long-term professional relationships with investigators and site staff
  • Mentor new CRAs, as needed (experienced CRAs only)
  • Travel frequency of up to 60%
Requirements
  • BA/BS/BSc degree or similar
  • Familiarity with ICH/GCP guidelines plus local codes of practice as applicable
  • Experience working as a CRA (working on industry-sponsored or industry-partnered clinical trials at academic institutions, or working on clinical trials at a biotech, pharmaceutical or CRO company)
  • Experience in early development (phase I/IIa) and/or oncology preferred
  • Attention to detail, organizational skills, time management

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