Study Coordinator

About the role

As a Study Coordinator at Sarah Cannon Research Institute (SCRI), you will play a crucial role in the execution and monitoring of complex clinical research protocols. Your responsibilities include planning the execution and completion of protocols, abstracting, assembling, and organizing research data, and ensuring adherence to the clinical protocol. You will also prepare reports on the data and work closely with the physician principal investigator, manager of data operations, clinical trial sponsor, and study team.

Responsibilities

• 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
• Lead the execution of trials for the research team
• Present in weekly protocol meetings to investigators, research staff, and management
• Provide pertinent safety information to sponsors 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 amendments or study changes
• Investigate root cause of major protocol deviations and manage the follow-ups 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
• Aid in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events
• Aid 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 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 SOP's established for clinical research
• Assist 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
• The ability to work independently in a fast-paced environment
• Interpersonal skills, detailed-oriented, and meticulous
• Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel

Qualifications

• 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 clinical trial processes

Skills

• Understanding of clinical trial data
• Knowledge of FDA guidelines and GCP
• Ability to work independently in a fast-paced environment
• Interpersonal skills, detailed-oriented, and meticulous
• Computer skills with ability to use clinical trial databases, electronic data capture, MS Access or Excel

Benefits

At Sarah Cannon Research Institute, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. Our Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being. For more information regarding benefits through our parent company, McKesson, please click here.

Pay

Compensation is determined by several factors, including performance, experience and 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.

Schedule

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.