Medella Life

Clinical Research Associate

Location
Italy (IT)
Salary
€40,000 Per Annum
Posted
10 Mar 2021
Closes
09 Apr 2021
Ref
242
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

The Company
My client is a European clinical CRO providing premium support for the management of global clinical trials from phase I to IV as well as pre- and post-marketing medical device investigations.

Founded in 1998, the company has 20 years of extensive experience in a wide range of therapeutic areas. Its recent oncology/immuno-oncology portfolio amounts to over 400 trials.

Their strength lies in its people and its specialized teams who assist clients from A-Z with medical writing, scientific and statistical consultancy for trial design and skilled teams of operational staff across Europe that ensure high quality project execution.

They are seeking a Clinical Research Associate based in Italy  to join their company.


Responsibilities

  • Collect the feasibility questionnaire (if applicable) and other documents necessary for the ethical and administrative submission
  • Check the willingness of the Investigator to cooperate so the study can take place according to the protocol guidelines and in compliance with ICH-GCP and legislation/regulations
  • Verify that the Investigator and staff are qualified for the study and have sufficient available time and resources/facilities
  • Verify that the Site is suitable with regard to its structure, instruments and the availability of patients affected by the pathology being studied
  • Ensure that the Investigator and staff have adequate training and act according to protocol
  • Ensure that essential documents are correctly signed and managed
  • Check that materials and drugs have arrived at the Site in due time
  • Train the Site staff according to the foreseen procedures and work instructions
  • Check the Investigator’s Folder prepared by the Documentation Service before it is sent to the Center
  • Update/check the Investigator’s Folder and the Trial Master File (paper and/or electronic, as applicable) according to the company and/or Sponsor procedures
  • Handle study materials, including study drug(s), as foreseen for the specific study and as applicable (drug supply and return, CRFs, laboratory material and samples, study documents, etc.)
  • Ensure that visits are performed according to contract
  • Contact Sites to check patient status, push enrolment, resolve queries and deal with various issues
  • Check that the enrolment schedule is in line with the study plan
  • Check adherence to inclusion/exclusion criteria
  • Check the correct completion of informed consent
  • Check the completeness and coherence of collected data and ensure that the confidentiality of the patient is respected
  • Check “source documents” according to the Monitoring Plan or other similar documents
  • Verify that serious adverse events have been reported using an SAE form, according to the company and/or Sponsor procedures
  • Properly and timely escalate relevant issues to his/her direct superior and to the Clinical Team (if applicable)
  • Gather all information about patients prematurely terminating the study
  • Collect CRF pages (if applicable) according to study procedures
  • Check drug accountability for each patient using an ad hoc form
  • Check that documents, drug and materials are stored properly
  • Check the expiration date of the investigational drug and act promptly to return drug to the Sponsor before it expires
  • In case of studies using electronic CRFs, prepare visits using a remote connection to check the completeness and consistency of information and data
  • Manage queries on an ongoing basis and within the timeframes set
  • Promptly manage and follow-up protocol deviations, interacting with the Clinical Team and the Site staff
  • Where applicable, perform visits remotely according to foreseen procedures and timeframes
  • Write up reports after each visit and each significant contact with the Investigator/Site staff within the timeframe required
  • Write up and sent follow-up communication to the Site staff according to the procedures and timeframes applicable for the study
  • Gather CRF corrections (signed and dated) when necessary and when applicable
  • Check and make sure that the Investigator has sent the Data Center all the collected data, according to Sponsor procedures in case of studies using electronic CRFs
  • Check the overall drug accountability
  • Update the information on study progress following the Sponsor’s requirements either in hardcopy or directly in the Sponsor’s systems
  • Enter all the information required in the TRACK system on an ongoing basis
  • Collect and return all residual materials (including drug) to the Sponsor
  • Participate in periodic meetings held by the Sponsor
  • Participate in the Investigator’s Meeting and Monitor’s Meeting
  • Maintain a proactive relationship with the Data Center


Connect

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.


Medella Life

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything

Similar jobs

Similar jobs