Senior Clinical Research Associate, Cell & Gene Therapy

WEP Clinical

. Oversee all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs .

Posted 6/8/2026full-timeRemote • 🇺🇸 United StatesSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Oversee all aspects of clinical monitoring and site management in compliance with GCP, global regulatory requirements, and WEP Clinical SOPs
Conduct on-site and remote monitoring to ensure protocol adherence
Maintain essential documentation and keep site and patient data inspection-ready
Build strong relationships with sponsors and sites
Serve as a key point of contact throughout the study
Support development of study-specific procedures (e.g., Monitoring Plans)
Assist in training or coordinating other CRAs

Requirements

What you’ll need

Bachelor’s degree (life sciences, nursing, or related field preferred)
5–7+ years’ experience conducting on-site and remote monitoring visits (or equivalent clinical research experience)
Senior CRA levelling: **SCRA I (3–5 yrs)** – independently manages complex sites; **SCRA II (5+ yrs)** – oversees complex sites/regions, mentors peers, and drives process improvements
Broad therapeutic exposure across multiple study types and indications
Strong technical/scientific aptitude with the ability to quickly grasp and execute clinical protocols
Advanced organizational and logistical skills; able to manage multiple sites/protocols within budget and timelines
Excellent written and verbal communication; confident stakeholder engagement
Solid understanding of medical/therapeutic areas and medical terminology
Proven ability to train, coach, and mentor clinical research staff
Proficient with MS Office and EDC systems; willing to travel up to 80%
Ability to remain in a stationary position for extended periods as part of normal day-to-day activities, with reasonable accommodations considered where appropriate

Benefits

Comp & perks

Medical, dental, and vision insurance
FSA, HSA
Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
Group short-term and long-term disability insurance
Group Life Insurance
401K safe harbor plan and company match
Paid vacation, holiday, sick and volunteer time
Paid maternity & paternity leave

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical monitoringsite managementprotocol adherencestudy-specific proceduresclinical research experiencecomplex site managementmedical terminologytrainingmentoringprocess improvements

Soft Skills

relationship buildingstakeholder engagementorganizational skillslogistical skillscommunication skillscoachingmentoringtechnical aptitudeproblem-solvingtime management

Certifications

SCRA ISCRA II