Study Coordinator

Sarah Cannon Research Institute•Nashville, TN

6d•Onsite

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. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team.

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

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 (including 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
Apprises 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 processioning
Review and responds to audit findings and escalates issues
Maintain and archive study documentation and correspondence per company policy
Reports 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 SOP’s established for clinical research
Assist internal quality team in preparation for sponsor and US FDA audit teams