Senior Clinical Research Associate

Summary

The Senior Clinical Research Associate manages the Data Coordinating Center for the multi-center observational study Aortic Valve Outcomes in Marfan Patients (AVOMP). This role leads the ongoing coordination of the AVOMP study, ensuring regulatory and protocol compliance across 14 academic centers, including 5 international sites. A key focus of this position is active collaboration within a larger research team framework. The Senior Clinical Research Associate also provides mentorship and guidance to junior staff and site-specific coordinators.

• Coordinates with investigators, institutions, sponsors, vendors, and regulatory bodies.
• Oversees all study-related documents, including newly created and revised regulatory documents (e.g., data use and material transfer agreements, institutional agreements, IRB protocols, and consent forms), and manages their execution.
• Manages agreements with study vendors (Omni Trace, WCG, Velos eResearch, and Tricefy).
• Creates and maintains vendor profiles for clinical sites and vendors in the payment procurement system.
• Assesses the quality and completeness of study visits, tracks the submission of source documents, determines payment eligibility, and records study visit completion rates.
• Receives invoices and processes payments for clinical sites participating in AVOMP (invoice request and receipt, PO request, and payment follow-up).
• Processes payments to vendors (invoice receipt, purchase order requests, and payment follow-up).
• Ensures adherence to the study protocol, including secure online data-entry systems (vendor: Velos eResearch), and coordinates with the Data Imaging and Tissue Bank Centers.
• Manages data collection and assesses data quality from multiple sites to ensure integrity, including systematic methods for opening and closing data queries.
• Manages data export, merging, and analysis, with expertise in advanced clinically oriented statistical methods (e.g., time-to-event analysis, repeated measures designs such as mixed-effects models, Cox regression modeling, multivariable logistic regression, weighting, survey methods, and the preparation of high-quality statistical figures for presentation and publication).
• Drafts original research abstracts for submission to academic conferences and related manuscripts; revises manuscripts as needed until journal acceptance.
• Develops and reviews protocol-specific documents and other study-related documentation.
• Trains new staff at clinical sites as needed.
• Provides quarterly updates to sites, the AVOMP PI, and the research team.
• Demonstrates familiarity with international agreements, including GDPR requirements.
• Maintains the project website.
• Performs other job-related duties as assigned.

• Bachelor’s degree.
• Four years of relevant experience.

• Master’s of Public Health or Medical degree in a related field.
• Advanced statistical analysis skills.
• Technical proficiency in research and data analysis tools, including:
  Statistical software:
  Stata, SPSS, Prism, GPower, R, Python.

Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.