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CTA

A Clinical Trial Assistant (CTA) will manage administrative tasks throughout the life stages of a clinical trial, supporting the QF Local Study Team with the submission, collecting, listing, maintaining, tracking and updating (as corresponds) of trial related documentation; being a relevant liaison with other parties of the clinical study (Health Authorities, research sites, CRAs and Sponsor, when applicable).
Full Time

Madrid, Spain

Experience required:

At least, 1 year at similar position.

Duties required:

  • Supporting, the Local Study Team collecting and tracking the documents and data required for regulatory submissions (contracts, financial agreements, patient informed consent forms, insurance certificates).
  • Performing study submission to Health authorities, initial, amendments, notifications, etc.
  • Maintaining and updating of the Trial Master File and preparation for relevant QC checks when applicable
  • Tracking site budget related matters, including processing invoices, tracking payments and for scheduling meetings, updating Excel trackers, coordinating the translation of site documents.
  • Train CTA trainees, if applicable.

Education and skills required:

  • Postgraduate studies or course of Clinical Trial Assistant (or equivalent), ongoing or finished.
  • Good command of written English.
  • Excellent organizational and prioritization skills.
  • Knowledge of Microsoft Office programs.
  • Attention to detail and excellent oral and written communication skills.

Senior CRA

Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites, perform on-site visits and training and mentoring of CRAs with less experience. Supporting activities to CTM regarding project management.
Full Time

Madrid, Spain

Experience required:

At least 1 year in a similar position.

Duties required:

  • Perform site selection, SIV, IMV and COV in clinical studies of new and established pharmaceuticals.
  • Responsible for support and management of sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
  • Obtain, maintain and review applicable clinical documentation in a timely manner.
  • Prepare and attend investigator meetings.
  • Participate in hosting pertinent audits/inspections when necessary.
  • Training and mentoring of CRAs with less experience.
  • Eventual support in the writing of company procedures.

Education and skills required:

  • Degree in life sciences or equivalent.
  • Master of Clinical Trials Monitoring.
  • Proven track record as an accomplished CRA in IMP trials (at least 4 years).
  • English: Fluent spoken & written.
  • Excellent communication and time management skills to manage multiple projects at any one time.
  • Strong team member and understand the need for effective communication at all levels.
  • Effective relationship building with sponsors, sites and colleagues, as well as strong management skills.
  • Responsible person, able to work with autonomy, dynamic and well organized.
  • Must be able to travel in accordance with company and project requirements.

CRA

Participate in pre-trial procedures, archiving documents and correspondence, setting up and organizing clinical trial sites and perform on-site visits.
Full Time

Madrid, Spain

Experience required:

At least 1 year in a similar position.

Duties required:

  • Perform in site selection, initiation, monitoring and close-out visits, plus maintaining appropriate documentation.
  • Support and management of the sites to ensure that projects are conducted in accordance with protocol, applicable regulation, and the latest ICH guidelines.
  • Managing progress by tracking case report form (CRF) completion and data query resolution.
  • Evaluating the quality and integrity of site practices – escalating quality issues as appropriate.
  • Cooperating and/or writing study plans and manuals.

Education and skills required:

  • Bachelor’s degree, or equivalent, in a scientific or healthcare discipline.
  • Master of Clinical Trials Monitoring.
  • Understanding of SOPs, WIs, EU, and local regulations as well as ICH GCP guidelines.
  • Good command of written and spoken English language.
  • Computer skills including use of Microsoft Word, Excel, and PowerPoint.
  • Willingness and ability to travel.
  • Responsible person, dynamic and organized, good team player.

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