Site Regulatory/ Data Coordinator

Site Data And Regulatory Coordinator

It's More Than a Career, It's a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer those who work to prevent it, fight it, and survive it are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

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

You should have for this position:

• 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.

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 850 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA in the past decade. SCRI's research network brings together more than 1,300 physicians who are enrolling patients into clinical trials at more than 200 locations in 20+ states across the U.S.

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. For more information regarding benefits through our parent company, McKesson, please click here.

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We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.