Clinical Research Coordinator

McKesson; Nashville, Northern (TN, KY); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

Total Rewards

Job summary

Sarah Cannon Research Institute (SCRI), a McKesson subsidiary in Nashville, seeks a Clinical Research Coordinator to manage clinical operations for oncology trials, including enrollment, regulatory, quality, and site operations.

You will enroll patients, review protocol criteria with physicians and patients, ensure informed consent, and maintain regulatory documentation and study data with monitors and teams across sites.

Qualifications

• Associate’s Degree, preferably a Bachelor’s Degree.
• Knowledge of medical and research terminology.
• Knowledge of FDA Code of Federal Regulations and GCP.
• Knowledge of the clinical research processes.
• Public presentation skills.
• Ability to manage multiple ongoing priorities and projects with a diverse team of professionals.

Responsibilities

• 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 physicians and patients.
• 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 CRFs or electronic data capture systems within study required timelines.
• You will ensure data integrity by source document review and monitoring for missing or implausible data.
• You will create study-specific tools for source documentation when not provided by sponsor.
• You will generate and track drug shipments, lab kits, and other supplies.
• You will maintain accurate documentation of protocol requirements according to SOPs.
• You will track and report adverse events, SAEs, protocol waivers, and deviations.
• You will maintain records including regulatory documents, informed consents, source documentation, drug logs, and study communications.
• You will coordinate regular site research meetings.
• You will attend on-site visits, investigator meetings, calls, and coordinator meetings with monitors and site staff.

Skills

Associate’s level knowledge

Medical terminology

FDA CFR knowledge

GCP knowledge

Clinical research processes

Public presentation skills

Multitasking with diverse team

Education

Associate’s Degree

Bachelor’s Degree preferred

Job description

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 youareresponsible foroverall clinical operations of the facility’s research program including enrollment, regulatory, quality, and site operations.

Responsibilities

• You will supportenrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements.
• You will reviewthe study design and inclusion/exclusion criteria with physiciansand patients
• You will ensurethe protection of study patients by verifying informed consent procedures and adhering to protocol requirements
• You will collect, complete, and enterdata into study specific case report forms (CRFs) or electronic data capture systems within study required timelines
• You will ensurethe integrity of the datasubmittedon case report forms or other data collection tools bycareful source document review and monitoringdata for missing or implausible data
• You will createstudy specific tools for source documentation when not provided by sponsor
• You will generate and trackdrug shipments, lab kits, and other supplies
• You willberesponsible foraccurateand complete documentation of protocol requirements according to site work instructions and standard operating procedures (SOPs)
• You will track and reportadverse events, serious adverse events, protocol waivers, and deviations
• You willmaintainaccurateand complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications
• You will coordinateregular site research meetings
• You will attendstudy-specific on-site meetings/visits, investigator meetings, conference calls, and other coordinator meetings, asrequiredand you will workclosely with monitors, study teams and site staff to ensure quality study data
• You will communicatesite status through a weekly activity report toappropriate site/managementcolleagues

You should have:

• AnAssociate’s Degree, preferably aBachelor’s Degree
• Knowledge of medical and research terminology
• KnowledgeofFDA Code of Federal Regulations and GCP
• Knowledge of the clinical research processes
• Public presentation skills
• The ability to manage multiple ongoing priorities and projectswith a diverse team of professionals

About Sarah Cannon Research Institute

We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson,

McKesson job postings are posted on our career site: careers.mckesson.com.

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.