Senior Clinical Research Associate

hace 3 semanas

Madrid, Madrid, España Tfs Healthscience A tiempo completo

About Tfs Healthscience

Tfs Healthscience is a leading Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service-capabilities, resourcing and functional service (FSP) solutions.

Job Description:

We are seeking a highly skilled Senior Clinical Research Associate to join our team in Madrid. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global biotech company that is an industry leader in onco-hematology.

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.
  • Initiate 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.
  • 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.

Requirements:

  • Bachelor's Degree, preferably in life science or nursing; or equivalent.
  • Minimum 4 years of experience working as a CRA.
  • Experience in oncology studies.
  • 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%.

What We Offer:

We provide a competitive compensation package of approximately **€55000 per year**, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You'll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.

About Us:

Tfs Healthscience is a full-service, global Contract Research Organization (CRO), building solution-driven teams working towards a healthier future. Bringing together over 800 professionals, Tfs delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making at all levels of the organization, fostering high employee engagement and satisfaction.

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