Study Coordinator

About the role

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

Responsibilities

• Lead the execution of trials for the research team.
• Plan and track all assigned clinical activity in the lifecycle phases of 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.
• Send notifications to the department before and after calls to update study staff.
• Present in weekly protocol meetings 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 (paper and/or EMR), are updated with any amendment(s) or study changes.
• Investigate the root cause of major protocol deviations and manage follow-up with responsible departments for corrective and preventative actions.
• Ensure pharmacy has Investigative Product and supplies.
• Interface with laboratory technicians 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 ensure 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 answer appropriate queries.
• Apprise 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 processing.
• Review and respond to audit findings and escalate issues.
• Maintain and archive study documentation and correspondence per company policy.
• Report patient visit and data entry information in the financial tracking system.
• Provide required metrics to leadership.
• Initiate improvements to enhance the efficiency and quality of the work performed on assigned projects.
• Adhere to professional standards and SOPs established for clinical research.
• Assist the internal quality team in preparation for sponsor and US FDA audit teams.

Requirements

• An understanding of clinical trial data.
• Knowledge of FDA guidelines and GCP is required.
• Ability to work independently in a fast-paced environment.
• Strong interpersonal skills, detail-oriented, and meticulous.
• Computer skills with the ability to use clinical trial databases, electronic data capture, MS Access, or Excel.
• Bachelor's 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 the 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.

Benefits

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 visit their benefits page.

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience, skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities, may be offered.