Clinical Research Coordinator for Clinical Trials

hace 3 días

Madrid, Madrid, España Empresa Reconocida A tiempo completo

Company Overview

At Empresa Reconocida, we transform healthcare by developing innovative tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health.

We are a leading provider of healthcare solutions, licensed at over 25,000 facilities in over 35 countries.

About the Role

We are seeking an experienced Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will play a key role in coordinating all monitoring activities related to clinical and non-interventional studies.

You will be responsible for coordinating country-specific activities in large multicountry studies, preparing study monitoring plans under the supervision of the Project Director/Senior Project Manager, and reviewing all monitoring reports according to the guidelines agreed with the Sponsor.

Key Responsibilities

  • Coordinate all monitoring activities related to clinical and non-interventional studies
  • Coordinate country-specific activities in large multicountry studies
  • Prepare study monitoring plans under the supervision of the Project Director/Senior Project Manager
  • Review all monitoring reports according to the guidelines agreed with the Sponsor
  • Supervise the filing of all study-related documentation in the Trial Master File as well as the documents provided by the Site (Investigator's file)
  • Supervise site activation and site management including monitoring activities (from feasibility to close out) in accordance with relevant parts of GCP/GPP/GEP, SOPs, the study protocol, and study plan in national and international clinical trials / non-interventional studies
  • Train CRAs / Clinical Trial Assistants (CTAs) on study-specific requirements
  • Develop project-specific training material for CRAs and study sites
  • Project-specific review of timelines and client's requirements regarding site management and monitoring activities; identification of critical issues at an early stage
  • Escalation Management, if required
  • Support of review of Standard Operating Procedures (SOPs) and engagement in process improvement initiatives
  • Contribution to or preparation of submissions and/or notifications to the Ethics Committees (EC) and, when applicable, to the Regulatory Authorities (RA)
  • Development and review of the Monitoring / Quality Review Plan
  • Contribution to the initial set-up, ongoing maintenance, and final distribution of the Study/Trial Master File
  • Preparation of the Investigator Site File and coordination of its distribution and ongoing maintenance of the respective sections of the Study/Trial Master File
  • Coordination and review of monitoring reports and follow-up communication
  • Review and preparation of essential study documents e.g., Patient Information and Informed Consent Form
  • Monitoring of the CRA visit schedule
  • If required, conduct of any kind of monitoring visit/call
  • Coordination and (if required) performance of co-monitoring activities as applicable

Qualifications

We are looking for a candidate with a minimum of 4 years of experience as CRA conducting monitoring, managing TMF, and initiating study sites for conducting clinical and/or non-interventional studies including Post-Authorization-Safety-Studies and degree educated. All employees must be legally authorized to work in the country where the position is located. Work visa sponsorship is not available for this position.

Salary

The estimated salary for this role is $80,000 - $110,000 per year, depending on experience.

Benefits

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

Location

This role is based in a location with a high quality of life and easy access to amenities.

About Us

Empresa Reconocida is a company that values diversity and inclusion. We are proud to be an equal opportunities employer and welcome applications from candidates of all backgrounds.

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