Senior Clinical Research Associate

TFS Chicago , IL 60290

Posted 2 weeks ago

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.

We are currently looking for experienced personnel with Ophthalmology therapeutic experience and ability to assist in other therapeutic areas when needed.

The Clinical Research Associate (CRA) is part of Clinical Monitoring within TFS and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and remote monitoring and termination of investigative sites during study conduct according to company policies, SOPs and regulatory requirements

Key responsibilities include:

  • Monitor on-site clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations and GCP and ICH guidelines
  • Review CRFs and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
  • Identify site problems/deficiencies and bring to the attention of management through trip reporting, memos and verbal communication with Project Manager or Lead CRA
  • Initiates corrective action to resolve issues as directed by supervisor
  • Contribute to the completion of the application to Ethics Committee/ IRB and prepare necessary documentation enclosed to the application according to local requirements in cooperation with CTA and directed by Lead CRA/Project Manager
  • Participate in contract handling and negotiation directed by Lead CRA/Project Manager
  • Set up ISF and SMF and distribute to the investigational sites
  • In cooperation with the study team, responsible for SMF maintenance
  • Order, ship and reconcile clinical investigative supplies for study sites if applicable
  • May prepare and submit status reports as directed by Lead CRA/PM
  • Review and support site staff to maintain SMF
  • Review Informed Consent documents for essential elements and protocol specifics
  • Update CTMS system with site and study information
  • May audit data in tables and text of clinical summaries
  • May assist in the preparation of study documentation such as CRF completion guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness
  • Prepare check requisitions for sponsor Project Management approval when applicablel

Requirements

  • Bachelor's degree preferably in life science or nursing or equivalent experience
  • 3-5 years of experience as a CRA including relevant experience in Ophthalmology therapeutic area
  • Able to work in a fast paced environment with changing priorities
  • Ability to work independently as well as in a team matrix organization
  • Excellent verbal and communication skills
  • Excellent organizational skills
  • Ability and willingness to travel 60-70%

Benefits

A great place to work where you will get the chance to push your career to the next level, global environment with global opportunities. You will also get the opportunity to be part of a team with highly intelligent, passionate experts from all over the world. TFS is a place for inspiration where we focus on the patients, saving lives and aiming to increase their quality of life by supporting our clients

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Senior Clinical Research Associate

TFS