Study Coordinator

McKesson•Nashville, TN

About The Position

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. 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. You are responsible for sending notifications out to the department before and after calls to update study staff. You will present in weekly protocol meetings to investigators, research staff, and management. You will provide pertinent safety information to sponsors 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 schedules, assessment windows, dose modifications, and central and local laboratory assessments. You will create study-specific tools for source documentation, including eligibility worksheets, screening checklists, and worksheets capturing vital signs and blood sampling (as applicable). You will ensure study-specific tools, including source documents (paper and/or EMR), are updated with any amendment(s) or study changes. You will investigate the root cause of major protocol deviations and manage follow-ups with responsible departments for corrective and preventative actions. You will ensure the pharmacy has Investigative Product and supplies. You will interface with the 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 ensure 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 a case report forms tracking management database. You will review trial data for clinical relevance and answer appropriate queries. You will apprise research scientists and the 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 processing. You will review and respond to audit findings and escalate issues. You will maintain and archive study documentation and correspondence per company policy. You will report patient visit and data entry information in the 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 SOPs established for clinical research. You will 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.
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.
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.

Nice To Haves

Bachelor Degree is preferred

Responsibilities

Plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols.
Abstract, assemble, and organize research data while monitoring adherence to the clinical protocol and preparing reports on the data.
Work closely with the physician principal investigator, manager of data operations, clinical trial sponsor, and study team.
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 (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.
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 escalates 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 the quality of the work performed on assigned projects.
Adhere to professional standards and SOPs established for clinical research.
Assist internal quality team in preparation for sponsor and US FDA audit teams.