Clinical Research Associate

Clinical Research Associate

TFS HealthScience

Seville or Málaga, Spain

Key Responsibilities

• Monitor on-site and remotely clinical trials in accordance with TFS and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines;
• Review CRFs (paper or electronic) 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, 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 (or cooperate with CTA) and distribute to the investigational sites;
• In cooperation with study team, responsible for SMF maintenance;
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable;
• Order, ship and coordination of study supplies at site;
• 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 Manager approval, when applicable.

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent;
• Minimum 1-2 years of experience working as a CRA (oncology desirable);
• Able to work in a fast paced environment with changing priorities;
• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas;
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines;
• Ability to work independently as well as in a team matrix organization;
• Excellent written and verbal communication skills;
• Excellent organizational skills;
• Ability and willingness to travel up to 60-70%.

Apply Now