Clinical Research Coordinator - Seville, Spain

Site Engagement and Recruitment Coordinator (Clinical Ops)

Location : Madrid, Community of Madrid, Spain

Experience : Minimum of 3 years of clinical trial experience, including previous experience as a Clinical Research Coordinator, Sponsor / CRO Clinical Research Associate, Study Nurse, or Site Director.

What are we looking for?

A Site Engagement and Recruitment Coordinator (SERC) who uses their strong clinical trial background and awareness of site engagement and recruitment tactics to support the clinical team in effectively planning for and achieving on-time enrollment. This position achieves these goals by working with the clinical team to proactively identify opportunities and challenges related to patient recruitment and retention. Supports the Global Clinical Operations Department by engaging, developing, and maintaining relationships with clinical investigation sites and overseeing clinical trial activities to ensure quality clinical trial execution and offer innovative solutions to recruitment and operational challenges. The SERC reports to a designated Senior Clinical Project Manager.

The challenge!

The Site and Recruitment Coordinator’s responsibilities include, but are not limited to :

• Awareness of and active participation in activities of site-related study execution of assigned studies, including feasibility, study start-up, execution, and close-out.
• Early participation in and management of study planning and preparation regarding site recruitment and retention plans, enrollment projections, and anticipated barriers to achieving on-time First Patient In.
• Support oversight efforts related to collaborating CRO activities, including but not limited to :
• Study delivery : including but not limited to site evaluation / selection discussions, contracts / budget negotiation, regulatory / EC submissions startup, issue management, relationship management, monitoring, and site closure facilitation.
• Quality oversight : Monitoring Visit Report Review; Site Visit for site quality oversight as appropriate.
• Escalate performance or quality issues and support the resolution of identified issues.
• Facilitate supplemental site training or other support from the Sponsor team as needed.
• Support audit and inspection readiness goals for sites on assigned studies.
• Assist with and follow up on-site audits, CAPA preparation, implementation, and follow-up communication.
• Independently serve as a key point of contact in the country or as a global representative for one or more studies.
• Drive project recruitment and retention strategy for assigned clinical trials by supporting the development of related communication to adapt, plan, and implement local study strategies for recruitment and retention.
• Participation in the review and finalization of key clinical trial documents, as assigned.
• Proactive and effective communication in collaboration with key internal & external stakeholders and third-party vendors. Develop partnerships (institutions and key investigator relationships) when appropriate and beneficial for the organization and / or assigned clinical trial(s).
• Lead investigational site engagement efforts :
• Define and implement strategies for successfully engaging clinical sites and investigators.
• Assist in identifying high-performing sites and key opinion leaders that can contribute to Exeltis forums, boards, and / or discussions.
• Support sites with enrollment barriers by reinforcing protocol-specific site recruitment plans, including review and approval of advertising campaigns.
• Provide operational expertise to sites through ownership / management to ensure the engagement of highly motivated clinical investigators.
• Support global team by participating in or leading other tasks and projects as assigned.

What do you need?

• Education : Bachelor’s degree (or international equivalent), preferably in a scientific or health-related field.
• Languages : Fluent in spoken and written English. Knowledge of other languages will be an asset, particularly local languages spoken within the regions of the assigned studies.
• Experience : Minimum of 3 years of clinical trial experience, including previous experience as a Clinical Research Coordinator, Sponsor / CRO Clinical Research Associate, Study Nurse, or Site Director. Prior CRA experience is essential for fulfilling flex role CRA tasks as necessary and assigned.
• Specific Knowledge : Prior experience conducting clinical research, including ICH-GCP knowledge and understanding, drug / device development process, regulatory compliance, regulatory agency requirements for clinical trials in the trial regions, study start-up, or study coordination.
• Travel Requirements : Required to travel approximately 40-50% of the time.
• Personal Skills : Strong communication skills, ability to focus on multiple deliverables simultaneously and deliver them on time, versatility and flexibility, general management skills, strong interpersonal and people development skills, results-oriented, superior leadership skills, superb organization skills, ability to anticipate problems and solve them successfully, and team player with the ability to work productively and independently in a remote professional environment.

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