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.

Responsibilities

• Provide support to the Clinical Research Coordinator (CRC) and Research Nurse daily
• Ensure all activities are conducted according to company SOPs and GCP/GMP guidelines
• Manage and track regulatory documents and protocol training to maintain site compliance for industry sponsors and GCP/FDA requirements
• Prepare for monitoring visits by printing and electronically filing regulatory paper documents
• Enter data into study-specific case report forms or electronic data capture systems for each assigned clinical trial
• Resolve queries for electronic data capture systems for each assigned clinical trial
• Meet industry trial data deadlines
• Establish an effective workflow with the Clinical Research Coordinator to effectively manage clinical trials
• Obtain source documentation for patients enrolled into clinical trials
• Auxiliary in SAE reporting and tracking
• 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 Study 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
• Track documents pending site regulatory signatures
• Routinely and track completion of protocol training
• Maintain FDA and GCP required regulatory documentation for individual site, studies, sponsors, and/or other networks
• Ensure all regulatory documentation is compliant with local SOPs for format and content
• Triage site requests for regulatory support and identify the 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

High school diploma or equivalent

Bachelor's degree in a relevant field preferred

Experience in a clinical research setting preferred

Knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP) preferred

Ability to work independently and as part of a team

Excellent organizational and time management skills

Strong attention to detail and accuracy

Ability to prioritize tasks and meet deadlines

Ability to communicate effectively both verbally and in writing

Ability to work in a fast-paced environment

Ability to travel as needed

Ability to lift and carry up to 25 pounds

Skills

Proficiency in MS Office

Strong organizational and prioritizing capabilities

Excellent attention to detail and accuracy

Ability to work independently and as part of a team

Strong communication skills (both verbal and written)

Ability to work in a fast-paced environment

Ability to lift and carry up to 25 pounds

Benefits

Comprehensive benefits package including health insurance, retirement plans, paid time off, and more

Pay

Competitive compensation package based on performance, experience, and skills

Schedule

Full-time position