Skip to main content

This job has expired

(Senior) Clinical Research Associate (s)CRA - sponsor-dedicated

Employer
Labcorp
Location
Germany
Salary
Competitive
Start date
13 Jun 2021
Closing date
13 Jul 2021

View more

Job Details


(Senior) Clinical Research Associate (s)CRA - sponsor-dedicated

Location: Munich, Germany / Home Office, Germany

A formula for clinical innovation: Labcorp Drug Development . With comprehensive drug development services and de-identified data from 70 million patients worldwide, our 60,000 employees advance life-changing medicines across a wide range of therapeutic areas. In this role, you will work directly with one of our renowned key sponsors and advance the development of innovative, life-changing medications for oncological therapies.

What we have to offer: a strong international support network, flexible working solutions that facilitate a genuine work-life balance, excellent career opportunities, a highly competitive compensation package and the opportunity to significantly raise your profile in the industry.

If you are looking to broaden your therapeutic expertise whilst gaining exposure within a world-class pharmaceutical working environment, we are looking forward to meeting you!

As (Senior) Clinical Research Associate, you typically will:
  • Own all aspects of site management as described in the project plans
  • Ensure the study staff conducting the protocol receive all materials and instructions to safely enter patients into the study
  • Protect study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible entries
  • Perform the required monitoring tasks in an efficient manner, according to SOPs and established guidelines; prepare accurate and timely trip reports
  • Review progress of projects and initiate appropriate actions to achieve target objectives
  • Interact with internal work groups to evaluate needs, resources and timelines
  • Act as contact for clinical trial suppliers and other vendors as assigned
  • Own the entire process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow ups on SAEs
  • Independently perform CRF reviews
  • Generate queries and resolve issues according to data review guidelines on Labcorp or sponsor data management systems
  • Assist with training, mentoring and development of new employees, e.g. co-monitoring
Education/Qualifications:
  • Degree in a relevant field such as life sciences, health care (management), nursing, biology, chemistry, pharmacology, (veterinarian) medicine, oecotrophology etc.
  • In lieu of the above, a completed equivalent higher vocational education with an appropriately accredited institution (e. g. licensed study nurse, study coordinator...)
Experience:
  • Proven experience in clinical research in a variety of therapeutic areas including oncology
  • Solid independent monitoring experience in Germany as (Senior / Lead) CRA and familiarity with applicable German regulations and authorities
  • Awareness of applicable clinical research regulatory requirements such as local regulations, GCP / ICH and the German regulatory authorities landscape
  • Working knowledge of Microsoft Word, Excel and PowerPoint
  • Effective time management and organizational skills and a keen attention to detail
  • Ability to establish and maintain effective, trustful working relationships with internal and external stakeholders
  • Excellent communication skills in both German and English -spoken and written - are a must


Remote

#LI-AR1

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert