Site Regulatory/ Data Coordinator

Sarah Cannon Research Institute•Austin, TX

1d•Onsite

About The Position

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. This position will work closely with the regulatory affairs department, site leadership and/or principle investigators to ensure compliance as well as preparing for auditing activities while meeting strict deadlines. You will enter data into study specific case report forms or electronic data capture systems for each assigned clinical trial. You will resolve queries for in electronic data capture systems for each assigned clinical trials. You will work with the Clinical Research Coordinator to meet industry trial data deadlines. You will establish an effective workflow with the Clinical Research Coordinator to effectively manage clinical trials. You will obtain source documentation for patients enrolled into clinical trials. Assist in SAE reporting and tracking. You will create and maintain patient visit tracking spreadsheets. You will create imaging requests, manages imaging tracker, answers queries, and uploads images per imaging guidelines for assigned clinical trials. You will establish and maintain positive relationship with Clinical Research Associates (CRA) You will investigate and report protocol deviations, when applicable You will maintain and archive study administrative files. You will maintain assigned closed to accrual trials. You will report required metrics to leadership team. You will attend all SIVs for assigned trials. You will schedule and manage monitor visits including resolution of follow up items. You will assist other colleagues as requested and performs other related work as needed. You will provide site level regulatory support to the site in relation to the status of start-up and ongoing regulatory maintenance You will establish and maintain a document management system for regulatory paper and electronic files for each study at the site You will escort monitors to and from the secured Monitoring Suite area You will maintain updated physician credentials and other critical documentation ensuring compliance You will meet with monitors, study sponsor representatives and auditors as requested You will track documents pending site regulatory signatures You will route and track completion of protocol training You will 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 You will triage site requests for regulatory support and identifies correct pathway for issue resolution You will maintain organization of Regulatory File room, including archiving notebooks as needed You will attend network meetings, conference calls and departmental meetings as appropriate You will provide administrative support to the Site Support department You will 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

Responsibilities

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
Managing and tracking regulatory documents and protocol training to maintain site compliance for industry sponsors and GCP/FDA requirements
Ensuring Regulatory paper documents are printed and electronically filed, in preparation for monitoring visits
Working closely with the regulatory affairs department, site leadership and/or principle investigators to ensure compliance
Preparing for auditing activities while meeting strict deadlines
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
Working with the Clinical Research Coordinator to meet industry trial data deadlines
Establishing an effective workflow with the Clinical Research Coordinator to effectively manage clinical trials
Obtaining source documentation for patients enrolled into clinical trials
Assisting in 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 relationship 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 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
Meeting with monitors, study sponsor representatives and auditors as requested
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
Ensuring all regulatory documentation is compliant with local Standard Operating Procedures (SOP’s) for format and content
Triaging site requests for regulatory support and identifying 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