Lead Clinical Research Associate

Lead Clinical Research Associate

TFS HealthScience

Madrid, Spain

The Lead CRA is responsible for coordinating and overseeing the country and site management activities during study conduct, according to company policies, SOPs and regulatory requirements in addition to financial and contractual obligations.

The Lead CRA may assist the Project Manager in certain aspects of project activities which may include country and site tracking, monitoring plans, review of monitoring reports and study monitoring resources management.

Key Responsibilities:

Support the Project Manager being responsible and accountable for overseeing all aspects of monitoring and site Management activities ensuring compliance with ICH/GCP guidelines, SOPs and protocol requirements.

• Lead, manage and guide CRAs being responsible for training and quality oversight of site management activities while proactively identifying potential operational issues and ensuring study deliverables.
• Development of Study Monitor plans, Monitor and Site Training plans, verification initiatives, coordinating Study Investigator Meetings and reviewing site and country Study Reports.
• Ensure study processes, procedures and expectations correspond to the practicality of conducting the trial from study feasibility through to close out.
• Serve as initial point of contact for the monitoring team and support them with investigative site personnel liaison.
• Implement monitoring/recruitment plans and support also the design of CRF completion guidelines.

Qualifications:

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• Minimum 3 years of experience as CRA including relevant on-site monitoring experience.
• Able to work in a fast paced environment with changing priorities.
• Understand the 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 and multiple projects.
• Excellent written and verbal communication skills as well as computer skills.
• Excellent organizational and Line Management skills.
• Ability and willingness to travel up to 10-20%.