Senior CRA — Global GI Trials Lead & Mentor

Alimentiv-2; San Diego (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Education Reimbursement program for全t-

Cell Phone and Remote Work Allowance

Office setup allowance

Travel program – up to 4 weeks/year

Flexible Summer Hours

Alimentiv Trust after 1 year

Mentorship program (Alimentorship)

Job summary

Alimentiv is seeking a Senior Clinical Research Associate to manage site monitoring and site management for trials across multiple regions, ensuring adherence to ICH-GCP and regulatory requirements. You will mentor junior CRAs and collaborate with sponsors, project teams and vendors to drive study delivery.

You will conduct on-site and remote monitoring, support site activation and recruitment, and maintain essential study documentation while traveling 40–60% and communicating effectively in

Qualifications

• Bachelor’s degree (Honours) in Life Sciences, Health Sciences, Pharmacy, Nursing or a related discipline; a Master’s degree is preferred.
• 4–6 years of relevant clinical research experience, with 7–9 years preferred.
• Strong clinical site monitoring experience across clinical trial activities from site start-up through close-out.
• Thorough knowledge of ICH-GCP, clinical research principles and applicable local regulatory requirements.

Responsibilities

• Independently conduct and document onsite and remote monitoring activities, including site qualification, initiation, monitoring and close-out visits.
• Ensure investigative sites comply with study protocols, ICH-GCP, applicable regulations, SOPs and project-specific requirements.
• Serve as a primary point of contact for assigned sites, managing site-related questions, issues and deviations through to resolution.
• Review clinical trial data, source documentation and study systems to ensure accuracy, data integrity and compliance.
• Support site selection, activation and recruitment activities to achieve milestones and patient targets.
• Ensure sites are trained on protocols and study systems throughout the study lifecycle.
• Maintain oversight of essential study documentation (ISF and TMF) and timely filing.
• Collaborate with sponsors, project teams, vendors and sites to support timelines and issue resolution.
• Participate in audits, Investigator Meetings and other project activities.
• Provide mentoring and CRA development support; participate in co-monitoring and process improvements.

Skills

Site monitoring

Regulatory knowledge

Communication

Mentoring juniors

Problem solving

Travel readiness

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences or related

Master’s degree preferred

Tools

EDC

IRT

eTMF

CTMS

Medidata Rave

Oracle InForm

Job description

Alimentiv is seeking a Senior Clinical Research Associate to manage site monitoring and site management for trials across multiple regions, ensuring adherence to ICH-GCP and regulatory requirements. You will mentor junior CRAs and collaborate with sponsors, project teams and vendors to drive study delivery.

You will conduct on-site and remote monitoring, support site activation and recruitment, and maintain essential study documentation while traveling 40–60% and communicating effectively in