Clinical Study Specialist I
About The Position
Are you a clinical operations professional who thrives on precision, compliance, and process efficiency? We are looking for an energetic Clinical Study Specialist I to join our growing Clinical Operations team and support the successful execution of innovative oncology clinical trials. In this role, you will be responsible for the operational success and integrity of site-level regulatory documentation, clinical monitoring visits, site initiation visits, close-out visits, and related action item follow-up. Acting as a central liaison between Project Management, Regulatory Affairs (RA), and Quality Assurance (QA), you will ensure that all site initiation activities (SIVs), monitoring preparation, conduct, and follow-up activities, as well as essential document collection (FDFs, CVs, and MLs), are executed with precision. You will own the action item lifecycle, driving compliance and monitoring readiness across a diverse portfolio of complex oncology trials.
Requirements
- 2+ years of hands-on experience in clinical research (CRO or pharma).
- Experience as a Field CRA, In-house CRA, or Study Startup Specialist is strongly preferred
- Understanding of Good Clinical Laboratory Practice (GCLP) and Good Documentation Practices (GDP) is required
- Familiarity with oncology protocols and their associated high-volume documentation (frequent amendments, complex lab kits, and staff logs)
- Experience navigating eTMF systems (e.g., Veeva Vault) and CTMS platforms
- Professional fluency in English is mandatory
- Strong organizational skills, keen attention to detail, and a proactive, solution-oriented approach
Responsibilities
- Review third-party monitoring visit reports, log Action Items (AIs), and actively drive them to resolution by following up directly with monitors and site staff
- Manage the collection, quality control, and filing of site-level essential documents (Financial Disclosure Forms, updated CVs, medical licenses, and laboratory certifications) required for Site Initiation Visits (SIVs) and site activation
- Oversee close-out logistics and documentation, ensuring complete reconciliation of all documents and resolution of all outstanding queries prior to formal site closure
- Prepare document packages for Regulatory Affairs (for EC and IRB submissions), track protocol amendments and ICFs, and conduct periodic gap analyses of eTMFs to maintain a constant state of audit readiness
- Manage site and monitor access to critical trial systems (EDC, IRT, and eTMF) and assist in organizing documentation for SIVs and investigator meetings
- Maintain central monitoring dashboards to provide Project Managers with real-time visibility into open action items and study compliance metrics
Benefits
- Medical, dental, and vision benefits
- 401(k) retirement savings plan with a healthy match
- Vacation and sick time
- Employee Assistance Program (EAP)
- Referral Program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
