Clinical Research Associate - Germany

Employer
OPIS
Location
Germany (DE)
Salary
Salary + benefits
Start date
16 Jan 2023
Closing date
15 Feb 2023

View more

Discipline
Clinical Research
Hours
Part Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
You need to sign in or create an account to save a job.

Job Details

We are a full-service CRO, expanding world-wide, offering stable career prospects and a variety of engaging projects to work on. Opis has been on the market for over two decades, therefore the career opportunities are stable and fruitful. We are committed to offering high-quality services, at an international level and we don`t like cutting corners!

Our extensive expertise can cover all phases of drug related trials in all the therapeutic areas as well as clinical investigations for medical and diagnostic devices, Investigator Initiated Trials (IITs), and compassionate use programs.

Due to our ongoing global expansion, we have a great opportunity for an experienced CRA to join our growing team in Germany, on a freelancing basis.

You are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements

 

Main tasks & responsibilities:

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP
  • Perform visits remotely according to foreseen applicable procedures and timeframes
  • Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
  • Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures
  • Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation

Requirements:

  • Life Science Degree
  • 2+ years experience as a CRA in another CRO, managing Clinical Trials
  • In depth knowledge of ICH GCP principles
  • Experience with phases II and III of CT
  • Ability to travel nation-wide
  • Fluent English and German

Benefits:

  • Salary + benefits
  • Bahn Card
  • VipDistrict discounts
  • Flexible hours
  • WFH (only the visits are sometimes performed on site)

 

Company

Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service, science driven biotech focused CRO providing premium trial management services for multi-national clinical trials, including state-of-the-art IT solutions and innovative approaches to the increasing complexity and variety of current projects.

OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.

Find Us
Website
Telephone
0039 362 6331
Location
Palazzo Aliprandi
Via Matteotti 10
Desio (MB)
Lombardy
20832
IT

Apply for Clinical Research Associate - Germany

Fields marked with an asterisk (*) are required

Your file must be a .doc, .pdf, .docx, or .rtf. No larger than 2MB
Selected file:

Click here to find out more about TopCV

Add a cover message

Which sectors are you interested in? required
Your communication preferences

When you apply for a job we will send your application to the named employer, who may contact you. By applying for a job listed on PharmiWeb.jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please contact us. All emails will contain a link in the footer to enable you to unsubscribe at any time.

You need to sign in or create an account to save a job.

Get job alerts

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

Create alert