Senior Clinical Research Associate – GI Trials Lead

Alimentiv; United States; Remote; USD 30,000 - 46,000; Full time

Benefits offered by this job

Education Reimbursement program for全-时

Monthly Cell Phone and Remote Work All

Office setup allowance

Working while visiting program

Flexible Summer Hours Program

Employee referral incentive

Trust program after year 1

Mentorship program (Alimentorship)

Job summary

Alimentiv is seeking a Senior Clinical Research Associate to independently manage site monitoring and site management across Poland, from start-up to close-out. You will be a primary contact for investigative sites, ensuring protocol adherence, data integrity, and regulatory compliance.

The role is senior, with mentoring responsibilities for junior CRAs, collaboration with Clinical Operations, and travel ~40–60% to meet milestones and recruitment targets.

Qualifications

• Bachelor’s degree in Life Sciences or related field; Master’s preferred.
• 7–9 years industry experience in clinical research; strong site monitoring background.
• Excellent knowledge of ICH-GCP, regulatory requirements, and trial management processes.
• Experience with Phase I–IV trials; proficient in trial systems (EDC/IRTs/ETMF/CTMS).

Responsibilities

• Independently conduct and document onsite and remote monitoring across Poland.
• Ensure sites comply with study protocols, ICH-GCP, and regulations.
• Serve as primary contact for assigned sites; manage queries and deviations to resolution.
• Assist with site selection, activation, and patient recruitment targets.
• Mentor CRA I/II colleagues and contribute to process improvements.

Skills

Clinical monitoring

Site management

ICH-GCP knowledge

Communication

Organization

Travel readiness

English proficiency

Education

Bachelor’s degree (Honours) in Life Sciences/Health Sciences/Pharmacy/Nursing or related

Master’s degree preferred

Tools

EDC

IRT

eTMF

CTMS

Medidata Rave

Oracle InForm

Microsoft Office

Job description

Alimentiv is seeking a Senior Clinical Research Associate to independently manage site monitoring and site management across Poland, from start-up to close-out. You will be a primary contact for investigative sites, ensuring protocol adherence, data integrity, and regulatory compliance.

The role is senior, with mentoring responsibilities for junior CRAs, collaboration with Clinical Operations, and travel ~40–60% to meet milestones and recruitment targets.