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Clinical Research Associate, Germany - L

Employer
ClinChoice
Location
Germany - Home-based
Salary
Competitive
Start date
1 Sep 2020
Closing date
30 Sep 2020

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
Job Title: Clinical Research Associate

Location: Germany

Schedule: Full time, Home-based

The role is open also for freelancers (FTE 0.4 - 0.5)

In this role you will be working in with our in-house team. You will be responsible for full site management from feasibility to close out of studies. We have a varied client base, ranging from small-mid sized Pharma and Medical Device companies.

Main Job Tasks and Responsibilities
  • Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • Performs training of site staff in all study procedures in order to ensure protocol/ICHGCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Adapts and translates Patient Information Leaflets and Informed Consent Forms
  • Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
  • Escalates any issues to relevant project team members
  • May assist in contract negotiation with sites on study budget after appropriate and documented training
  • May support the submission process in the project (or region)


Education and Experience
  • You have a University Degree in scientific medical or paramedical discipline
  • Prior experience as a CRA
  • Excellent knowledge of clinical trial operations, ICH-GCP Guidelines and other applicable regulatory requirement
  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook
  • Willingness to travel


If you have the experience needed for this position, please apply directly @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002308

If you would like to discuss the role before applying through the website please contact alessandra.bolognani@cromsource.com for more information

Why CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organization who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Keywords

CRA, Clinical Research Associate, Clinical Research, CRO, Clinical Research Organisation, Clinical Trials, Clinical, submissions, Clinical Research ICH-GCP, Monitoring, Home based, Germany, Deutschland
Skills: Clinical Research Associate, CRO, ICH-GCP, Monitoring Location: Germany - Home-based Share:

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Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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