Inhouse Clinical research associate (CRA)

We are actively looking for inhouse CRA's for one of our clients. Our client is a sponsor with an innovative pipeline. You will be part of an international team.

  • Do you have previous clinical research experience, or experience with data review, EDC, site start-up, site contact?
  • Can you work independently, pro-active, and do you learn easily?
  • Are you fluent in English?

Then this might be the perfect position for you, find out more below!

Job Description 

As an Inhouse CRA you play a crucial part in the smooth conduct of the Clinical research process.

Responsibilities 

Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to :

  • Assists in the development of study related materials such as: patient brochures, patient recruitment material, and presentations.
  • Assists in writing sections of the protocol summary, annual report and other study reports.
  • Assists in the development and review of informed consent document to ensure all required elements are included.
  • Assists with site nomination, qualification, and selection processes.
  • In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site.
  • Coordinates activities with study specific committees, vendor services, and core labs.
  • Reviews and analyzes data and documents for accuracy and completeness. Creates and processes data queries.
  • Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
  • Reviews and processes product complaints and adverse events as soon as they are reported.
  • Drafts Serious Adverse Event narratives

Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate.

  • Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards. Notify appropriate study management when concerns exit.
Profile 
  • A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.
  • Minimum 1 year of clinical research experience (for example as a Data Manager, Study Coordinator, CRA, ...)
  • A general familiarity with clinical trials research processes. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment.
  • Must have demonstrated strong written and verbal communication in English, any other European language is a plus. 
  • Next, you have strong interpersonal, presentation, analytical, and the ability to interpret basic clinical data,
  • You are able to meet deadlines and have good organizational skills
  • Familiarity with Microsoft Word, Excel and Outlook programs and relevant clinical applications.
  • The ability to work independently when necessary.
  • The ability to exchange straightforward information, ask questions, and check for understanding.
Contact Information 

Ellie Depape
ellie.depape@valesta.com
015 21 11 04

Application form : Inhouse Clinical research associate (CRA)

Files must be less than 3 MB.
Allowed file types: txt rtf html pdf doc docx odt.

I want to stay informed.

I would like to receive Valesta news, valuable insights into industry trends, career opportunities, trainings, and other helpful tips to find assignments that match my skills and interests. Click here to stay connected with Valesta.

Valesta is an expert in life science recruiting and project staffing.  The information you are submitting is important for us to respond to your assignment and contract needs. In compliance with the General Data Protection Regulation (EU) 2016/679) (“GDPR”), Valesta will process your personal data in accordance with our Privacy Policy. Valesta will safeguard your personal information and not disclose to any person unlawfully. As a staffing company, Valesta receives and processes your personal data for the following purpose: to take appropriate steps to find you an assignment with one of our clients and/or to finalise a contract with you.

Please note that Valesta does not wish to receive any data from you if you are under the age of eighteen (18) or data that is classified as Sensitive Data under the GDPR; this includes personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership, genetic/biometric/health-related data or data concerning a person's sex life/sexual orientation.

Please read our disclaimer.