Senior CRA - EU GI Clinical Trials Lead & Mentor

Alimentiv; United States; Remote; USD 67.000 - 101.000; Vollzeit

Benefits dieser Stelle

Education reimbursement

Cell phone allowance

Office setup allowance

Working while visiting program

Flexible summer hours

Referral incentive

Alimentorship program

Zusammenfassung

Alimentiv is seeking a Senior Clinical Research Associate to manage site monitoring and site management across Portugal and Spain, from start-up to close-out. You will serve as a primary contact for investigative sites, ensuring compliance with protocols, ICH-GCP, and study requirements while supporting high-quality data delivery.

This senior role includes mentoring junior CRAs, handling issues, and maintaining study documentation in a dynamic clinical research environment.

Qualifikationen

• Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing or related discipline (Master’s preferred).
• 4–6 years clinical research experience; 7–9 years preferred.
• Strong site monitoring across trial activities (start-up through close-out).
• Thorough knowledge of ICH-GCP and local regulatory requirements.
• Experience with Phase I–IV trials; proficient in CTMS/EDC systems.

Aufgaben

• Independently conduct on-site and remote monitoring across Portugal and Spain.
• Ensure sites comply with study protocols, GCP, regulations and SOPs.
• Serve as primary contact for assigned sites; manage questions and deviations to resolution.
• Review trial data, source docs, and study systems for accuracy and compliance.
• Support site activation, recruitment, training, and documentation maintenance.
• Collaborate with sponsors, project teams and vendors to meet timelines.

Kenntnisse

Site monitoring

ICH-GCP

Regulatory knowledge

Trial systems

Ausbildung

Bachelor’s degree in Life Sciences or related

Master’s degree preferred

Tools

Medidata Rave

Oracle InForm

EDC systems

CTMS

Jobbeschreibung

Alimentiv is seeking a Senior Clinical Research Associate to manage site monitoring and site management across Portugal and Spain, from start-up to close-out. You will serve as a primary contact for investigative sites, ensuring compliance with protocols, ICH-GCP, and study requirements while supporting high-quality data delivery.

This senior role includes mentoring junior CRAs, handling issues, and maintaining study documentation in a dynamic clinical research environment.