Clinical Research Coordinator

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, 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.

About the Role

As the Clinical Research Coordinator you are responsible for overall clinical operations of the facility's research program including enrollment, regulatory, quality, and site operations. You will support enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.

Responsibilities

• Review the study design and inclusion/exclusion criteria with physicians and patients
• Ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements
• Collect, complete, and enter data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines
• Ensure the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible data
• Create study specific tools for source documentation when not provided by sponsor
• Generate and track drug shipments, lab kits, and other supplies
• Be responsible for accurate and complete documentation of protocol requirements according to site work instructions and standard operating procedures (SOPs)
• Track and report adverse events, serious adverse events, protocol waivers, and deviations
• Maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications
• Coordinate regular site research meetings
• Attend study-specific on-site meetings/visits, investigator meetings, conference calls, and other coordinator meetings, as required
• Work closely with monitors, study teams and site staff to ensure quality study data
• Communicate site status through a weekly activity report to appropriate site/management colleagues

Qualifications

• An Associate's Degree, preferably a Bachelor's Degree
• Knowledge of medical and research terminology
• Knowledge of FDA Code of Federal Regulations and GCP
• Knowledge of the clinical research processes
• Public presentation skills
• The ability to manage multiple ongoing priorities and projects with a diverse team of professionals