Clinical Research Coordinator

McKesson•Gainesville, FL

About The Position

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 Clinical Research Coordinator for Blood Cancer and Bone Marrow Transplant (BMT) research you are responsible for overall clinical operations of the facility’s blood cancer research program including enrollment, regulatory, quality, and site operations. You will support enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. You will review the study design and inclusion/exclusion criteria with physician s and patient s You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements You will collect, complete, and enter data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines You will ensure the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible data You will cr eate study specific tools for source documentation when not provided by sponsor You will generate and track drug shipments, lab ki ts, and other supplies You will be r esponsible for accurate and complete documentation of protocol requirements acco rding to site work instructions and standard operating procedures ( SOPs ) You will track and report adverse events, serious adverse events, protocol waivers, and deviations You will maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications You will coordinate regular site research meetings You will attend study-specific on-site meetings/visits, investigator meetings, conference calls, and other co ordinator meetings, as and you will work closely with monitors, study teams and site staff to ensure quality study data You will communicate site status through a weekly activity report to appropriate site/management colleagues

Requirements

An Associate’s Degree , preferably a Bachelor’s Degree
Knowledge of m edical and research terminology
Knowledge of FDA Code of Federal Regulations and GCP
Knowledge of the clinical research processes
Public presentation skills
The ability to manage multiple ongoing priorities and projects with a diverse team of professionals
At least one year of oncology experience, preferably in hematology/ oncology and /or transplant
At least one year of experience in a clinical research setting

Nice To Haves

At least one year of experience managing blood cancer and/or BMT clinical trials is preferred
Research certification (ACRP or CCRP) is preferred
RN or LPN is preferred

Responsibilities

overall clinical operations of the facility’s blood cancer research program including enrollment, regulatory, quality, and site operations
support enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements
review the study design and inclusion/exclusion criteria with physician s and patient s
ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements
collect, complete, and enter data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines
ensure the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible data
cr eate study specific tools for source documentation when not provided by sponsor
generate and track drug shipments, lab ki ts, and other supplies
be r esponsible for accurate and complete documentation of protocol requirements acco rding to site work instructions and standard operating procedures ( SOPs )
track and report adverse events, serious adverse events, protocol waivers, and deviations
maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications
coordinate regular site research meetings
attend study-specific on-site meetings/visits, investigator meetings, conference calls, and other co ordinator meetings, as and you will work closely with monitors, study teams and site staff to ensure quality study data
communicate site status through a weekly activity report to appropriate site/management colleagues