Clinical Trials Coordinator
WK Medical Center
Cancer Center - Cancer Center-Cancer Research
8:00 AM-4:30 PM
Function as coordinator, consultant, educator and researcher in all aspects of a clinical trial management. Incumbent must exercise initiative and be able to make independent decisions and establish independent work routines.
Listed below is an outline of the major duties and responsibilities that you will be required to perform. As a Clinical Trials Coordinator you are
delegated the authority, responsibility and accountability to carry out your assigned duties.
Promote the Willis-Knighton Health System and Physician Practice to the pharmaceutical industry and other research organizations as a study site for testing and development of new treatment strategies in oncology.
Act as liaison between physician investigators and study sponsors.
Prepare and submit documents to the Institutional Review Board (IRB),including the development of appropriate consent forms consistent with legal, IRB, Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) requirements.
Develop methods for tracking patient registration and treatment in clinical trials.
Assure that quality control and quality assurance guidelines are met.
Review records with site visit teams, the FDA lnst1tue or other agents as required.
Prepare reports and provide statistical information as needed by sponsors, the IRB or other entities.
Order investigational drugs as needed for protocol purposes and maintain investigational drug records when appropriate. Otherwise, advise and assist pharmacy personnel in the maintenance of such records.
Periodically review investigational drug logs and inventories with pharmacy staff to assure that appropriate documentation is maintained and that Federal guidelines are being met.
Coordinate with pathology, radiation therapy, and surgery departments when protocol specific data submission is required from these departments.
Develop methods for identifying and recruiting eligible patients for clinical trials.
Participate in continuing education activities as related to oncology and other areas to improve knowledge for job performance.
Participate in the education of other health-care professionals, patients and families regarding clinical trials, protocol development, program administration, and research program audit.
Assist physician with the informed process. Assure that subjects are informed of protocol procedures, and of changes in the studies on which they are participating. Maintain awareness of protection of subjects and their rights.
Conduct continuous study, analysis and evaluation of research procedures in order to improve methods for accomplishing research goals.
Performs related responsibilities as required. Coordinate with physician investigator to obtain all pre-treatment measures, ascertain eligibility of all potential protocol patients prior to enrollment.
Coordinate with physician investigator to obtain all pre-treatment measures, ascertain eligibility of all potential patients prior to enrollment: formally register all patients, collect, abstract, and report all data as dictated by the treatment protocol
Participate in case management of protocol participants by monitoring treatment plans. Consult with and advise physician investigators to assure adherence to protocol design.
Schedule appointments or tests, in consultation with physician, as needed for protocol compliance.
Report adverse event/adverse drug reactions (AE's/ADR's) according to appropriate protocol and governmental guidelines. Alert investigators about communications from sponsors regarding AEs/ADRs.
Maintain updated protocol documents.
Qualifications-Bachelor's Degree in health information systems, nursing, the life sciences, or a health related field.
2-5 years experience in medical field or in clinical research. Certification as a Clinical Research Professional desirable.
Excellent written and verbal skills. Ability to communicate effectively at all levels.
Ability to interpret and analyze complex numerical and written information to arrive at logical conclusions.
Must be willing to adapt work schedule to needs, which may sometimes require additional efforts.
Must be willing to travel overnight from time to time in order to receive required protocol specific training and job-related education.
Basic computer skills. Typing proficiency.
Willis-Knighton is an equal opportunity employer and thus, manages its employment and employee relations policies, practices and benefits without regard to age, race, sex, color, creed, religion, national origin, disability, veteran, or other protected status where otherwise qualified.