Clinical Research Coordinator

This Coordinator in the Feist-Weiller Cancer Center at LSUHSC-S is a professional healthcare team member. The incumbent will function as a clinical research coordinator of NCI sponsored cooperative group, industry sponsored, and in-house investigator initiated clinical research trials carried on through the Feist-Weiller Cancer Center. This will include not only treatment trials, but also cancer control and prevention trials as mandated by the NCORP grant award or the Associate Director for Cancer Prevention and Control.

Incumbent will be responsible for carrying out work to its completion under general supervision of the Director, Medical Service Area and the faculty investigators conducting the research in the Feist-Weiller Cancer Center. Incumbent will also assist in the conduct of clinical trials at Feist-Weiller Cancer Centers affiliate sites established through its NCORP grant award.

Incumbent must have an in-depth understanding of all regulatory guidelines set forth in the Code of Federal Regulations, ICH Guidelines, Good Clinical Practice, 1-IIPAA, and the LSUHSC-S IRB and Clinical Trials Office pertaining to the conduct of clinical research in human subjects. Incumbent will act as administrative liaison between the M.D./Ph.D. Principal Investigator and all cooperative groups, industry sponsors, the Investigational Review Board, and all federal regulatory agencies.

Job duties involve specialized work requiring knowledge of the clinical trial process in order to recruit and evaluate appropriate research trial participants. Specific duties include patient recruitment and assessment of patient eligibility, enrollment in appropriate trials, implementation of treatment or other research plans according to protocol guidelines, case management of protocol subjects, management of study drug supplies and drug accountability, education of other healthcare professionals, patients, and families regarding clinical trial participation, timely and accurate collection and submission of research data to clinical trial sponsors, completion of long-term follow-up of study patients, chart preparation for and participation in all quality assurance, FDA, and NCI audits, timely maintenance of in-house patient management database, completion of study queries, compilation, analysis and verification of statistics, initiation of and response to correspondence related to research activities, assistance with training additional affiliate sites in the conduct of clinical trials.

This position differs from a clinical research associate position in that it is focused on the specialty of the patients clinical care and/or cancer prevention care as well as the protocol-driven tasks. In addition to providing and coordinating clinical care, clinical research coordinators have a central role in assuring participant safety, ongoing maintenance of informed consent, integrity of protocol implementation, accuracy of data collection, data recording and follow-up.

Care received by research participants is driven by study requirements and the collection of research data related to clinical indications. Study procedures may include administration of investigational drugs, performance of an experimental or investigational procedure, detailed clinical assessment or phenotyping to characterize the natural history and etiology of a disease, or delivery of a psychosocial intervention. Additional clinical care may be necessitated by the response of the participant to the study intervention.

The incumbent must be able to make independent decisions and establish independent work routine. This will be a dedicated full-time position. Regular attendance is required to perform the functions of this position.

Essential Position Functions & Duties

50% Protocol Management

• Adhere to the requirements of assigned clinical trial protocols.
• Assist the investigator, Director, Business Manager and other clinical research personnel in pretrial evaluation, cost certification and budget and contract preparation.
• Actively participate in subject recruitment.
• Participate in health fairs and cancer screening programs for recruitment of patients to cancer control and prevention trials.
• Review all eligibility criteria and follow-up requirements and screen patients according to criteria.
• Educate patients about the purpose of the clinical trial and study procedures.
• Assure consenting process is completed and documented.
• Enroll eligible subjects who have signed consent on study.
• Coordinate pretreatment and follow-up tests, ancillary department material submission, study drug supply, and patient scheduling as needed.
• Collect and submit data on appropriate forms according to the protocol.
• Ensure treatment plans are carried out correctly and adhere to the protocol guidelines.
• Assure that the most current IRB approved version of the protocol and consent form is used for patient enrollment.
• Re-consent patients as needed in accordance with all protocol and consent form amendments.
• Review eligibility criteria and source documents submitted by affiliate sites to verify patient eligibility.
• Assist affiliate sites to ensure accurate implementation of protocol procedures.
• This may include travel to affiliate sites for audit purposes when necessary.
• This may also include performance of study-related duties on the mobile screening vehicles.
• Schedules and/or performs procedures such as patient interviews, counseling, collection of vital signs, medication administration, venipunctures and other specimen collection within the privileges granted by incumbents licensure.
• Report Adverse Events according to the National Cancer Institute (NCI), sponsoring agency and local Institutional Review Board (IRB) by completion and submission of appropriate forms.
• Prepare patient charts for quality assurance audits and be present at audits.
• Communicate with Coordinator of Research Studies Billing and assist in accurate billing for study charges.
• Identify which study drugs are supplied by the study, order drugs in a timely manner in order to ensure that patients are treated with study-supplied drugs, and alert research pharmacist when such drugs are being ordered for a study.
• Conduct close out procedures for pharmaceutical studies including preparation of patient charts for final monitor visit, notification of IRB personnel and assisting the Coordinator of Research Billing in final disposition of charges.
• Complete and maintain written records to document the flow of data.
• Maintain research records to include, but not limited to, flow sheets, pre-study forms, treatment forms, toxicity forms, serious adverse event forms, off-study forms, eligibility, checklists and informed consent.
• Identify and flag copies of source documentation in the research record.
• Provide accurate, complete, legible and timely documentation on protocol-specific forms consistent with source documents for the life of the subject or as long as protocol dictates.
• Accurately document Toxicities and Response Assessments.
• Monitor drug dose calculations and follow laboratory results to ensure dose modifications are made as needed.
• Identify any treatment modification or alteration between protocol study and the treatment administered.
• Explain variances or lack of protocol adherence.
• Assist affiliate sites in accurate completion of case report forms.
• Assist affiliate sites in completion and timely submission of all study patient queries.
• Assure that a system of drug accountability and documentation is maintained.
• Order and coordinate research drug shipments from the National Cancer Institute (NCI) or other suppliers of investigational drugs.
• Appropriately return or dispose of drugs as indicated per protocol or standard industry practice.
• Ensure appropriate storage and handling of study drugs as per protocol or standard industry practice.
• Assure maintenance of drug transfer forms, return forms and shipping receipts.
• Review Investigational Drug logs, Drug Accountability Review Forms and inventories with pharmacy staff and study.
• Assure compliance with research regulatory bodies.
• Maintain documentation according to the Food and Drug Administration (FDA) Code of Federal Regulations (CFR) and the Institutional Conference on Harmonization Consolidated Guidelines (ICH).
• Adhere to the Institutional Review Board (IRB) policies, procedures, and ethics for the protection of human research subjects.
• Communicate with affiliate sites that operate under the LSUHSC-S IRB and ensure that sites are using current approved IRB documents.
• Adhere to the National Cancer Institutes (NCI) Investigational Drug Accountability Record Form (DARF) requirements.
• Package shipments of biologically hazardous materials according to OSHA guidelines.
• Adhere to LSU Compliance Programs Code of Conduct.
• Accurately utilize electronic databases and Web sites.
• Enter each patient protocol registration in the appropriate Feist-Weiller Cancer Center electronic databases.
• Update databases on a regular and timely basis.
• Perform Cooperative Group registrations via the group web site as allowed per protocol.
• Perform study registrations via sponsors web site as required per protocol.
• Regularly access web site to assure current information being used.
• Participate in electronic database training and continuing education.
• Review and adhere to electronic database updates and policy changes.
• Assist affiliate sites in the operation and maintenance of the electronic database.

20% Clinical Care

• Specialty focus on the care of research participants.
• In addition to providing and coordinating clinical care, clinical research coordinators have a central role in assuring participant safety, Care received by research participants is driven by study requirements and the collection of research data as well as clinical indications.
• Study procedures may include administration of investigational drugs, performance of an experimental or investigational surgical or radiological procedure, detailed clinical assessment or phenotyping to characterize the natural history and etiology of a disease, or delivery of a psychosocial intervention.
• Additional clinical care may be necessitated by the response of the participant to the study intervention.

10% Communication

• Communicates with patient, significant other, the healthcare team and external agencies.
• Consult and collaborate with physician/faculty investigators and the interdisciplinary healthcare team to follow treatment protocol.
• Coordinate information and support other Coordinators in the Feist-Weiller Cancer Center.
• Collaborate on a regular basis with Coordinator of Research Studies Billing to assure an accurate record of patient procedures and to identify which are research related or standard of care.
• Serve as the primary point of contact between the investigator and the patient and patient families and keep patient informed of all protocol treatment issues.
• Respond effectively and quickly to situations.
• Establish effective working relationships with other departments as needed.
• Confer with outside physicians and other healthcare team members to obtain data as required.
• Coordinate monitoring activities with physician/faculty investigators, protocol representatives and the Director of Clinical Research.
• Develop effective communication with patient, significant other and/or family.
• Collaborate with the Cancer Center Business Manager regarding financial aspects of studies.
• Maintain communication with affiliate sites in support and assist in their continued education of the research process.

10% Education

• Plans and provide educational activities for patients, significant others and staff members.
• Plan and provide patients with educational