Senior Clinical Research Associate I

hace 4 semanas


Madrid, Madrid, España Fortrea A tiempo completo

Fortrea is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

The Senior Clinical Research Associate I is responsible for site monitoring and site management according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.

The Senior Clinical Research Associate I assures the implementation of project plans, as assigned, and functions as a leader for projects of limited scope.

Responsibilities may include acting in the project role of a Local Project Coordinator or Lead CRA as assigned.

Summary of Responsibilities:

Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaising with vendors.

Responsible for all aspects of site management as prescribed in the project plans.

General On-Site Monitoring Responsibilities:

Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.

Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.

Monitor data for missing or implausible data.

Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks efficiently according to SOPs and established guidelines, including managing travel expenses economically.

Ensure audit readiness at the site level.

Prepare accurate and timely trip reports.

Manage small projects under the direction of a Project Manager/Director as assigned.

Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans and trip report review as assigned.

Review progress of projects and initiate appropriate actions to achieve target objectives.

Organize and make presentations at Investigator Meetings.

Participate in the development of protocols and Case Report Forms as assigned.

Interact with internal work groups to evaluate needs, resources, and timelines.

Responsible for all aspects of registry management as prescribed in the project plans.

Conduct, report, and follow-up on Quality Control (QC) visits when requested.

Recruit potential investigators and prepare EC submissions as instructed.

Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.



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