- Company Name
- Cynosure Staffing
- Job Title
- Senior Clinical Research Associate
- Job Description
-
**Job Title**
Senior Clinical Research Associate
**Role Summary**
Drive late‑stage clinical trial execution, ensuring compliance with ICH/GCP, FDA regulations, and internal SOPs. Lead site monitoring activities, coordinate cross‑functional teams, and manage risks to meet study milestones within budgets.
**Expectations**
- 4–6 years of clinical monitoring experience in late‑stage, global studies.
- Proven ability to manage site initiation, routine monitoring, CRA oversight, and study close‑out.
- Strong vendor management skills (central labs, imaging, IRT).
- Willingness to travel 75 % of the time (US & international).
- Self‑motivated, collaborative, and adaptable to a start‑up environment.
**Key Responsibilities**
- Plan, conduct, and document site visits (initiation, routine, CRA oversight, close‑out).
- Monitor regulatory and protocol compliance, identify action items, and ensure timely resolution.
- Support centralized monitoring, data quality oversight, and risk mitigation between on‑site visits.
- Coordinate site activations, database locks, and investigator meetings to meet study deadlines.
- Maintain study files, logs, manuals, and templates; track ancillary supplies and specimens.
- Provide progress updates to Clinical Operations Leads and stakeholders.
- Facilitate audit preparation and follow‑up.
- Propose and implement process improvements and contingency plans.
**Required Skills**
- Deep knowledge of ICH/GCP, FDA regulatory requirements, SOPs, and drug development processes.
- Vendor management experience (central lab, imaging, IRT).
- Proficient in MS Office (Word, Excel, PowerPoint, SharePoint).
- Excellent written and verbal communication.
- Strong organizational, time‑management, and problem‑solving abilities.
- Team‑player mindset with a record of cross‑functional collaboration.
**Required Education & Certifications**
- Bachelor’s degree (or equivalent) in a relevant scientific field.
- Experience in small/emerging biotech is preferred.
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Dallas-fort worth metroplex, United states
On site
Senior
10-02-2026