Details:
- Compensation: $155,000 - $165,000k
- Benefits: Medical, Dental, Vision
- Employment Classification: Direct Hire
- Status: On-Site
- Job ID: 22034
ClinLab Solutions Group is seeking a Lead Clinical Research Associate to support our client, an ophthalmology-focused biotech company advancing treatments for patients with vision-threatening disease. This role sits above the site-facing CRA team, providing oversight, quality review, and mentorship across one or more studies. It is a strong fit for an experienced CRA ready to step back from a full-time travel schedule and into a leadership role, while still staying close enough to the field to keep sites and studies on track.
ClinLab connects scientific talent with the companies advancing the next generation of therapies — from early discovery through clinical development and into commercialization.
ClinLab connects scientific talent with the companies advancing the next generation of therapies — from early discovery through clinical development and into commercialization.
KEY RESPONSIBILITIES
- Provide day-to-day leadership, guidance, and mentorship to a team of CRAs, serving as an escalation point for site and study issues.
- Conduct CRA oversight (co-monitoring) visits to assess monitoring quality, GCP compliance, and consistency across the team.
- Review monitoring visit reports for quality, completeness, and consistency; provide timely, constructive feedback to report writers.
- Oversee and coordinate report reviewers, ensuring turnaround times and quality standards are consistently met across the team.
- Maintain a small, personal site caseload (approximately 1–2 sites), staying hands-on and credible with the field-based team.
- Partner with clinical operations, project leadership, and data management to identify trends, risks, and training needs across sites.
- Support onboarding and training of new CRAs, including shadow visits and monitoring plan walkthroughs.
- Travel as needed to support oversight visits, team meetings, and the CRA's own site caseload.
REQUIRED QUALIFICATIONS
- Bachelor's degree in a life science, nursing, or related field (or equivalent experience).
- Significant CRA experience, including demonstrated independent management of a full site caseload.
- Prior experience providing feedback, mentorship, or informal leadership to other CRAs is strongly preferred.
- Strong report-writing and report-review skills, with a sharp eye for quality and consistency.
- Excellent organizational, written, and verbal communication skills.
- Sound working knowledge of ICH-GCP and applicable regulatory requirements.
- Willingness to travel on a limited basis to support oversight visits and a small personal caseload.
PREFERRED QUALIFICATIONS
- Prior monitoring experience in ophthalmology or retina studies is a plus, though not required.
- Experience across both CRO and biotech/sponsor-side environments is a plus.
- Prior experience in a Lead CRA, Senior CRA II, or CRA mentor/trainer capacity.