Clinical Research Coordinator
Decatur Memorial Hospital
||72320 Clinical Research
||Full Time 40 HRS
||Mon - Fri 8:00-4:30
Manages Research Study Activities.
Essential Functions and Job Duties
• Coordinates screening and enrollment of clinical trial patients.
o Ensures eligibility requirements are met and reviews with investigator.
o Assists investigator in explaining and educating patient and family on protocol and informed consent.
o Obtains informed consent from potential study candidates and / or families.
o Continues informed consent process with study patients through duration of participation
o Obtains re-consent in a timely manner
o Manages patient enrollment via guidelines established by study protocol.
o Ensures protocol required testing is ordered and completed as outlined in the study protocol.
o Coordinates study-setup
o Screens EMR routinely for potential study patients
o Maintains screening records and patient accruals in CREDIT database
• Performs data management activities for clinical trials
o Gathers and verifies source documents.
o Abstracts and submits accurate data as requested.
o Verifies the accuracy, completeness and timely submission of case report forms.
o Corrects and resubmits data or answers queries within a timely manner per the study sponsors guidelines.
o Utilizes computer software to collate and report abstracted data elements.
o Maintains a record keeping system that documents patients/participants registered on research studies, their protocol status, copies of the informed consent, and the data submitted.
o Review patient records for identification of potential adverse events or protocol deviations.
o Redacts all patient documents and imaging data prior to submission to research bases
o Reviews and prepares charts for audits
o Serves as a liaison to research base auditors and pharma monitors
• Maintains investigational drug (IND) inventory
o Reviews protocols and assesses current inventory of IND.
o Orders INDs from Pharmaceutical Management Branch at National Cancer Institute or trial sponsor.
o Maintains inventory on individual drug accountability records.
o Ensures treatment order is correct by reviewing protocol guidelines and calculating dose prescribed.
o Assesses each IND for expiration dates and follows protocol and department guidelines for drug destruction.
• Order and track laboratory kits needed for research related blood draws. Process and ship specimens as required by protocol. Maintain hazardous materials education certification.
• Demonstrates clinical competency by providing direct patient care as required by protocol (EKGs, vitals, lab draws). Obtains protocol specific training as required to enroll patients on clinical trials.
• Performs protocol reviews prior to implementation and stays current on protocol amendments
• Serves as a professional resource regarding clinical trials, protocol procedures and protocol compliance for investigators, nurses, pharmacists, pathologist, radiologists and other health care personnel.
• Trains new study coordinators on job duties/functions and assesses competence
• Attends cancer conference to provide information about current protocol availability for presented cases.
• Attends NCI research base meetings for updates on clinical trials
• Attends Investigator Meetings.
• Attends educational workshops and / or conferences as time allows when requested.
• Participates in activities such as continuing education, community work, and quality improvement to promote professional development.
• Demonstrates a knowledge and compliance with GCP guidelines in the conduction of clinical research.
• Performs other duties as assigned.
A bachelors degree in nursing or other health-related field is preferred. Pertinent LPN or RN licensure/registration must be maintained if applicable. Previous research experience and/or recent nursing experience is preferred.