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Sarah Cannon Research Institute · 2 days ago

Study Coordinator

Nashville, TN

Full-time

Onsite

Entry Level

1+ years exp

Sarah Cannon Research Institute (SCRI) is a leading oncology research organization focused on advancing therapies for cancer patients. The Study Coordinator will plan, execute, and monitor clinical research protocols while ensuring adherence to clinical protocols and preparing reports on research data.

Research

Responsibilities

You will lead the execution of trials for the research team

You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out

You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians

You will verify study procedures are performed within the protocol specified window

You will 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

You will present in weekly protocol meeting to investigators, research staff, and management

You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria

You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments

You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable)

You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes

You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions

You will ensure pharmacy has Investigative Product and supplies

You will interface with laboratory technician for lab kits and processing

You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations

You will participate in monitor visits for each assigned trial at each monitoring visit

You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items

You will review source documentation and queries for missing documentation

You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe

You will maintain case report forms tracking management database

You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance

You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events

You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning

You will review and responds to audit findings and escalates issues

You will maintain and archive study documentation and correspondence per company policy

You will reports patient visit and data entry information in financial tracking system

You will provide required metrics to leadership

You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects

You will adhere to professional standards and SOP’s established for clinical research

You will assist internal quality team in preparation for sponsor and US FDA audit teams

Qualification

Clinical trial managementFDA guidelines knowledgeGCP knowledgeData entry skillsResearch data analysisComputer skillsInterpersonal skillsDetail-orientedWork independently