Site Regulatory/ Data Coordinator

About the role

The primary responsibility of the Site Data and Regulatory Coordinator is providing support to the Clinical Research Coordinator (CRC) and Research Nurse daily, ensuring all activities are conducted according to company standard operating procedures (SOPs) and all applicable Good Clinical Practice (GCP) and ICH regulations and guidelines. In addition, managing and tracking regulatory documents and protocol training to maintain site compliance for industry sponsors and GCP/FDA requirements and ensuring Regulatory paper documents are printed and electronically filed, in preparation for monitoring visits.

Responsibilities

• Supporting the Clinical Research Coordinator and Research Nurse daily
• Maintaining site compliance for industry sponsors and GCP/FDA requirements
• Managing and tracking regulatory documents and protocol training
• Preparing for auditing activities
• Entering data into study specific case report forms or electronic data capture systems for each assigned clinical trial
• Resolving queries for in electronic data capture systems for each assigned clinical trials
• Maintaining workflow with the Clinical Research Coordinator to effectively manage clinical trials
• Obtaining source documentation for patients enrolled into clinical trials
• Aiding in Serious Adverse Event (SAE) reporting and tracking
• Creating and maintaining patient visit tracking spreadsheets
• Creating imaging requests, managing imaging tracker, answering queries, and uploading images per imaging guidelines for assigned clinical trials
• Establishing and maintaining positive relationships with Clinical Research Associates (CRA)
• Investigating and reporting protocol deviations, when applicable
• Maintaining and archiving study administrative files
• Maintaining assigned closed to accrual trials
• Reporting required metrics to leadership team
• Attending all Source Investigator Visits (SIVs) for assigned trials
• Scheduling and managing monitor visits including resolution of follow up items
• Assisting other colleagues as requested and performing other related work as needed
• Providing site level regulatory support to the site in relation to the status of start-up and ongoing regulatory maintenance
• Establishing and maintaining a document management system for regulatory paper and electronic files for each study at the site
• Escorting monitors to and from the secured Monitoring Suite area
• Maintaining updated physician credentials and other critical documentation ensuring compliance
• Tracking documents pending site regulatory signatures
• Routing and tracking completion of protocol training
• Maintaining FDA and GCP required regulatory documentation for individual site, studies, sponsors and/or other networks
• Triage site requests for regulatory support and identifies correct pathway for issue resolution
• Maintaining organization of Regulatory File room, including archiving notebooks as needed
• Attending network meetings, conference calls and departmental meetings as appropriate
• Providing administrative support to the Site Support department
• Participating in educational activities and programs

Requirements

Knowledge of scientific, medical, and regulatory terms preferred
Knowledge of GCP and GMP
MS Office
Professional writing and communication skills
Organizational and prioritizing capabilities
Strong computer skills with demonstrated ability using clinical trial databases, electronic data capture, Microsoft Office (Outlook, Word, Excel, and PowerPoint) and SharePoint.

Benefits

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves.

Pay

This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.

Schedule

Compensation details are determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.