Clinical Research Coordinator

McKesson•Denver, CO

8d•$79,000 - $89,000

About The Position

As the Clinical Research Coordinator for Blood Cancer and Bone Marrow Transplant (BMT) research, you are responsible for the 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 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-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 create study-specific tools for source documentation when not provided by the sponsor. You will generate and track drug shipments, lab kits, and other supplies. You will be responsible for accurate and complete documentation of protocol requirements according 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 coordinator meetings, as required, 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 medical 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
At least one year of experience managing blood cancer and/or BMT clinical trials is preferred

Nice To Haves

Research certification (ACRP or CCRP) is preferred
RN or LPN is preferred

Responsibilities

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 physicians and patients.
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.
Create study-specific tools for source documentation when not provided by sponsor.
Generate and track drug shipments, lab kits, and other supplies.
Responsible for accurate and complete documentation of protocol requirements according 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 coordinator meetings, as required.
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.