CRA I - sponsor-dedicated, regional monitoring Southern Germany

Employer
Syneos Health
Location
Munich (Stadt), Bayern (DE)
Salary
40- 43,000
Closing date
7 Oct 2020

View more

Discipline
Clinical Research, Clinical Research Associate
Hours
Full Time
Contract Type
Permanent
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We are currently recruiting for the CRA sponsor -dedicated  to  be home-based on the south part of  Germany.  This is an excellent permanent opportunity where one can develop their skill set further and work on exciting studies of a well-known and established pharmaceutical company.

Major Responsibilities:

- Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements.
- Evaluate overall performance of site and site staff.
- Ensure compliance and understanding of study requirements by site contacts.
- Ensure adequate enrolement.
- Apply knowledge to resolve basic site issues.
- Identify and escalate more complex issues.
- Interpret data to identify protocol deviations or major risks data integrity.
- Understand and interpret protocol and regulations to ensure sites are inspection-ready.
- Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
- Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
- Review and verify case report forms and other clinical data for completeness and accuracy.
- Monitor patient safety, identify and address any protocol deviations.
- Recommend appropriate follow-up responses, generate queries and manage resolutions with site personnel.
- Participate in the identification and selection of investigators and clinical sites.
- Maintain project tracking systems as required.
- Complete assigned training programs and apply learning.
- Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations.

 

The ideal candidate will need the following experience / skills to be considered:   


• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• 0 – 2 years prior clinical research/monitoring experience
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and other applicable regulatory requirements
• Strong organizational skills
• Must demonstrate good computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Heavy travel required (up to 60%)
• Fluency in German and a high level of English language are required

Syneos-header

Syneos Health™ (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 23,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to life® visit syneoshealth.com.

Please visit our Careers Hub on PharmiWeb.Jobs:www.pharmiweb.jobs/minisites/syneos-careers-hub/

Contact Us
  • Corporate Headquarters
  • 3201 Beechleaf Court
  • Morrisville
  • 27560
  • US
  • +1 919 844 7100
  • Mini-site: Syneos Health
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