Clinical Research Coordinator

As the Clinical Research Coordinator you are responsible for overall clinical operations of the facility's 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 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

You should have:

• 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