Clinical Research Associate - Germany

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)