Study Coordinator

Join Sarah Cannon Research Institute

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.

As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team.

Key Responsibilities

• Lead the execution of trials for the research team
• Plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out
• Confirm patient eligibility and discuss discrepancies with nursing staff and physicians
• Verify study procedures are performed within the protocol specified window
• Participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff
• Present in weekly protocol meeting to investigators, research staff, and management
• Provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria
• Update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments
• Create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)
• Ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes
• Investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions
• Ensure pharmacy has Investigative Product and supplies
• Interface with laboratory technician for lab kits and processing
• Track and report adverse events, serious adverse events, protocol waivers, deviations and violations
• Participate in monitor visits for each assigned trial at each monitoring visit
• Review and comment on monitor letters within 5 business days of receipt and insures resolution of open items
• Review source documentation and queries for missing documentation
• Collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe
• Maintain case report forms tracking management database
• Review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance
• Assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events
• Assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning
• Review and responds to audit findings and escalates issues
• Maintain and archive study documentation and correspondence per company policy
• Reports patient visit and data entry information in financial tracking system.
• Provide required metrics to leadership
• Initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects
• Adhere to professional standards and SOP's established for clinical research
• Assist internal quality team in preparation for sponsor and US FDA audit teams

Qualifications

• An understanding of clinical trial data.
• Knowledge of FDA guidelines and GCP is required.
• The ability to work independently in a fast paced environment.
• Interpersonal skills, detailed-oriented and meticulous.
• Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel
• Bachelor Degree is preferred
• At least one year of experience in healthcare, research or other science related field
• At least one year of experience planning and managing clinical trial process

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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