Clinical Research Associate

TFS is a Global CRO headquartered in Sweden. We genuinely believe that “Global in mind and local at heart” is the core of our success; we operate in a global environment while retaining an in-depth knowledge of regulatory requirements in every country where we operate. At TFS, you will be offered the possibility to develop in a global organization with a company culture distinguished by passion, innovation and talent.

TFS is currently looking to hire various CRA's to be fully dedicated to an extraordinary sponsor.

Key responsibilities

• Obtain and maintain essential documentation in compliance with ICH-GCP, TFS procedural documents and local regulations both in trial master file (TMF) and investigator study file (ISF).
• Actively participate in local study team meetings.
• Contribute to the selection of potential investigators.
• Train, support and advise investigators and site staff in study related matters.
• Contribute to national investigators meetings.
• Initiate, monitor and close study sites in compliance with TFS procedural documents. Share information on patient recruitment and study site progress within local study team.
• Drive performance at the sites. Proactively identify study-related issues, solutions and escalate as appropriate.
• Update CTMS and other systems with data from centers as per required timelines.
• Manage study supplies (ISF, CRF, etc), drug supplies and drug accountability at study sites.
• Perform source data verification according to SDV plan.
• Oversee data query resolution by the site.
• Verify accurate and timely reporting of serious adverse events.
• Prepare for activities associated with audits and regulatory inspections in liaison with local study delivery team lead and CQM.
• Provide the required monitoring visit reports within required timelines.
• Work with data management to confirm quality of the study data.
• Support and work together with lead CRA, LSM and regulatory affairs to see to timely delivery of study documents for submissions to RA and EC.
• Contribute to financial agreements with relevant staff at investigational site in collaboration with lead CRA and/or LSM.
• Oversee timely preparation of country specific CSA in collaboration with LSM and/or lead CRA.
• Verify compliance with TFS’s code of conduct and company policies and procedures relating to people, finance, technology, security and safety, health and environment.
• Track and manage agreed payments at study site level.
• Participate in training and mentoring of new members of the local study team verifying compliance with ICH/GCP and TFS procedural documents.
• Confirm that all study documents are ready for final archiving and sign-off completion of local part of the trial master file.
• Contribute to process improvements, knowledge transfer and best practice sharing.
• Actively share applicable information that may be relevant to marketing and sales and the MC medical department and in accordance with corporate ethical guidelines.

Requirements

• Have a Bachelor's degree or equivalent combination of education and experience.
• Have substantial experience in field monitoring as a Senior CRA with Contract Research organisation (CRO) experience.
• Possess strong problem solving, organizational and time management skills.
• Are able to multi-task and attend to detail.
• Are great at planning, well organized and can work calmly under pressure.
• Have therapeutic area experience in rare diseases

Benefits

• The opportunity to be part of a friendly, supportive team and work with exciting technologies
• Home based flexibility
• Competitive salary
• Opportunity to work on a complex trial in challenging therapeutic area