CTA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As a Clinical Trial Assistant you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Partners with the CTM and CRA to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.

• Supports the local study team in performing site feasibility and/or country feasibility.

• Maintains site level protocol information in Trial Management Systems (e.g. CTMS).

• In liaison with the CTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.

• Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process.

• Supports the CTM or, where applicable the CRA, in providing the current and complete documents requested by the IEC/IRB and HA.

• Supports the CRA/CTM in collecting and maintaining all documents throughout the trial and posttrial in both eTMF and paper files.

• Distributes, collect, review, and track regulatory documents, agreements and training documentation.

• Collects and tracks Financial Disclosure information at appropriate time points.

• Complies with relevant training requirements.

• Region specific (to be specified):

  o Negotiates site requested changes to the Confidential Disclosure Agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations. 
  o Prepares Trial Center File and prepare or co-ordinate the development of any other document and review them for completeness and accuracy.
  o Assist the CTM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting.
  o May be assigned to assist in document review for outsourced trials.
  o Support the CTM in drug distribution process.
  o Provide administrative and logistical support to the CTM/CRA in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate

• Archives off-site paper Trial Master File.

You are:

• A BA/BS degree is preferred
• Skills set corresponding with preferentially 1-2 years relevant clinical trial experience or equivalent.
• Proficient in English language and local labguage (Portuges).
• Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
• Strong interpersonal and negotiating skills.
• Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner.

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.