Site Regulatory/ Data Coordinator

About the role

The Site Data and Regulatory Coordinator provides 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. This position works closely with the regulatory affairs department, site leadership, and/or principle investigators to ensure compliance and prepares for auditing activities while meeting strict deadlines.

Responsibilities

• Enter data into study specific case report forms or electronic data capture systems for each assigned clinical trial.
• Resolve queries for each assigned clinical trial in electronic data capture systems.
• Work with the Clinical Research Coordinator to meet industry trial data deadlines.
• Create and maintain patient visit tracking spreadsheets.
• Create imaging requests, manage imaging tracker, answer queries, and upload images per imaging guidelines for assigned clinical trials.
• Establish and maintain positive relationships with Clinical Research Associates (CRA).
• Investigate and report protocol deviations, when applicable.
• Maintain and archive study administrative files.
• Maintain assigned closed to accrual trials.
• Report required metrics to leadership team.
• Attend all Site Investigator Visits (SIVs) for assigned trials.
• Schedule and manage monitor visits including resolution of follow-up items.
• Assist other colleagues as requested and perform other related work as needed.
• Provide site level regulatory support to the site in relation to the status of start-up and ongoing regulatory maintenance.
• Establish and maintain a document management system for regulatory paper and electronic files for each study at the site.
• Escort monitors to and from the secured Monitoring Suite area.
• Maintain updated physician credentials and other critical documentation ensuring compliance.
• Meet with monitors, study sponsor representatives, and auditors as requested.
• Track documents pending site regulatory signatures.
• Routinely track completion of protocol training.
• Maintain FDA and GCP required regulatory documentation for individual site, studies, sponsors, and/or other networks. Ensures all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content.
• Triage site requests for regulatory support and identifies correct pathway for issue resolution.
• Maintain organization of Regulatory File room, including archiving notebooks as needed.
• Attend network meetings, conference calls, and departmental meetings as appropriate.
• Provide administrative support to the Site Support department.
• Participate 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.

Qualifications

• Bachelor’s degree in a relevant field (e.g., Biomedical Science, Nursing, Pharmacy, etc.)
• Minimum of 2 years of experience in a clinical research setting.
• Experience with electronic data capture systems.
• Experience with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

Skills

• Excellent written and verbal communication skills.
• Proficiency in MS Office applications.
• Ability to prioritize tasks and manage multiple projects simultaneously.
• Strong organizational and analytical skills.
• Experience with electronic data capture systems.
• Understanding of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).

Benefits

We not only care about the wellbeing of our patients, customers, and the communities we serve — we care about you. That’s why we provide our employees with a comprehensive support system for all aspects of Your Care: physical, emotional, financial, and social.