Study Coordinator

Study Coordinator

It's More Than a Career, It's a Mission.

Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day.

Our Mission

People who live with cancer those who work to prevent it, fight it, and survive it are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

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.

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 follow-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 report 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

You should have for this role:

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

Bachelor 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 process

Pay range $29.33/hr - $35.00/hr

About Sarah Cannon Research Institute

Sarah Cannon Research Institute (SCRI) 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 750 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 today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S.

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.