Coordinate and drive operational activities across assigned study workstreams (e.g., start-up, enrollment, monitoring, database lock, close-out), working under the Study Lead.
Maintain and update study trackers, timelines, and deliverable logs; proactively escalate timeline risks and propose mitigation plans.
Manage CROs and external vendors across all phases of study start-up, conduct, and close-out, ensuring deliverables are on time, within budget, and fully compliant with GCP, SOPs, and regulatory requirements.
Provide oversight of clinical monitoring activities, including review of monitoring visit reports and conduct monitoring oversight visits to confirm adherence to study protocols and quality standards.
Participate in cross-functional and vendor operational meetings as required; document decisions and action items.
Oversee site-level operational activities such as specimen management, subject visit tracking, and timely data review to identify trends, discrepancies, and potential risks.
Contribute to site feasibility, selection, and initiation activities while supporting the development and approval of essential study documents, including monitoring plans, ICFs, CRFs, pharmacy, and laboratory manuals.
Oversee study supply management, review site and study budgets, and evaluate CRO/vendor invoices to ensure financial accountability and transparency.
Ensure the Trial Master File is current, accurate, and inspection-ready.
Participate in Investigator Meetings
Support protocol and study report development

Requirements

BA/BS in life sciences, nursing, or related field (or equivalent work experience)
At least 5 years of progressive experience in clinical operations, clinical research, or a CRO/pharma environment
Direct experience with site management, monitoring, or clinical operations duties (site visit experience required)
Hands-on experience with eTMF systems and clinical data systems (EDC), and competency in common study tracking tools (Excel, Smartsheet, etc.)
Working knowledge of ICH-GCP and applicable regulatory requirements (FDA/EMA)
Strong organizational skills, attention to detail, and the ability to manage competing priorities
Excellent interpersonal and written/verbal communication skills; comfortable coordinating across functional teams

Benefits

Market-leading compensation
401(k) with employer match
Employee Stock Purchase Program (ESPP)
Pre-tax commuter benefits (transit and parking)
Referral bonus for hired candidates
Subsidized lunch and parking on in-office days
100% employer-paid medical, dental, and vision premiums for you and your dependents
Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)
Fertility & family-forming benefits
Expanded mental health support (therapy and coaching resources)
Hybrid work model with flexibility
Flexible, “take-what-you-need” paid time off and company-paid holidays
Comprehensive paid medical and parental leave to care for yourself and your family

Applicant Tracking System Keywords

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

Hard Skills & Tools

clinical operationsclinical researchsite managementmonitoringstudy trackingdata reviewfinancial accountabilityprotocol developmentstudy report developmentrisk management

Soft Skills

organizational skillsattention to detailability to manage competing prioritiesinterpersonal skillswritten communicationverbal communication