The primary purpose of the Clinical Studies Coordinator [Patient Care] position is to ensure that the integrity and quality of clinical trials are maintained and conducted in accordance w/ federal, state, and local regulations, Institutional Review Board (IRB) approvals, and OMRC policies and procedures, thus protecting the health, safety and welfare of research participants under the guidance of the Principal Investigator (PI) and in close collaboration with the Protocol Team.
The Clinical Studies Coordinator [Patient Care] will be responsible for clinical trials that pose ' Minimal Risk ' or ' Greater than Minimal Risk ' to research subjects. Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected (as defined in eCFR §46.102). Greater than Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research risks are more than minimal risk, but not significantly greater. In addition, the Clinical Studies Coordinator [Patient Care] may assist a Research Nurse for the execution and communication of clinical trials that pose ' Significantly Greater than Minimal Risk ' to research subjects. ' Significantly Greater than Minimal Risk ' to subjects means that there is a probability of an event that is serious, prolonged and/or permanent occurring as a result of study participation or there is significant uncertainty about the nature or likelihood of adverse events.Key FunctionsClinical Trial Execution
Clinical Trial Communication
- In collaboration with the Principal Investigator, Protocol Team, sponsor(s) and supporter(s) assumes responsibility for the effective and safe operation of research protocols.
- Demonstrates intimate knowledge of protocol content and mandated procedures, consistently following the most recent IRB approved version of the protocol.
- Maintains up to date knowledge of departmental and institutional databases and tools for execution of clinical trial workflow such as ePRTCL, CORe, Prometheus, ClinicalTrials.gov, Microsoft Office and others as indicated.
- Collaborates with the Protocol Team in the pre-activation set up of the protocol in departmental and institutional databases and in the proper execution of the clinical trial.
- Prepares for, attends and participates in all Study Initiation visit(s).
- Communicates frequently and effectively with Protocol Team in order to maintain up to date knowledge of all assigned protocol(s) participants' status.
- Participates in the informed consent process to enable and ensure its proper execution.
- Conducts successful patient recruitment, scheduling and retention through the accurate assessment of patients for protocol eligibility (through personal interviews as well as retrieval and detailed review of medical records from internal and external healthcare facilities as needed) in the outpatient and inpatient settings.
- Monitors and coordinates the care of protocol participants in the inpatient and outpatient clinical settings ensuring protocol mandated evaluations and treatments are accurately fulfilled.
- Generates required documentation and disposes of left-over investigational drugs as per departmental and institutional mandates.
- Identifies adverse events experienced by study participants and facilitates their management and follow-up under the guidance of the treating provider and Principal Investigator, until resolution or other, as per protocol mandate.
- Identifies and addresses patient and caregivers' education needs regarding treatments and evaluations on protocol via in-person, telephone, video conferencing tools and/or appropriate written education material, as needed.
- Must be able to independently manage assignments without supervision.
Training and Professional Development
- Demonstrates excellent verbal and written communication skills.
- Effectively communicates the participants' experience on the study to the PI, the IRB, the protocol sponsor(s) and supporter(s) and regulatory agencies by generating timely documentation of relevant information and results of study mandated evaluations in the patient's medical record (and other platforms as needed) as per protocol, departmental and institutional requirements.
- Provides detailed and timely initial and follow-up documentation of the adverse events encountered by study participants.
- Provides accurate attribution to study interventions or other (under the guidance of the treating provider and the PI) of the adverse events encountered by study participants.
- Communicates and collaborates with the Protocol Team to address, in a sufficient, appropriate and timely manner, any protocol deviations and violations identified during the course of the study.
- Communicates and collaborates with the Protocol Team to organize and coordinate protocol. monitoring visits and audits, and provide sufficient, appropriate and timely responses to sponsor or auditor queries.
- Communicates and collaborates with the Protocol team to provide sufficient, appropriate and timely submission of protocol summaries to the PI, the IRB, the protocol sponsor(s) and supporter(s) and additional regulatory agencies, as per protocol, departmental and institutional requirements.
- Assists the Protocol Team with budgeting and research related charges for assigned protocols.
- Coordinates and attends all PI meetings and assists the Protocol Team with protocol data assembly and interpretation as needed.
- Participates in the development of policies, procedures and work flow processes to ensure project efficiency and effectiveness, as needed.
- Demonstrates proactive and effective oral and written communication skills when contacting other institutions, patients, and agencies (i.e., NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email, and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
- Maintains a high level of professional expertise and technical proficiency with regards to clinical research through reading, attendance to appropriate departmental meetings, in-services and institutional continuing education programs
- Maintains appropriate license and certification
- Adopts novel technologies as needed to adapt to the evolving landscape of clinical research
- Completes all departmental protocol related training and delegation of authority documents in an accurate and timely manner
- Completes all mandatory institutional training requirements
- Consults with Supervisor and/or Research Nurse Manager regarding ongoing study assignments
- Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process
- Maintains a working knowledge of departmental clinical trial workflow in order to communicate with the Protocol Team for proper execution of trial procedures.
- Participates in the orientation process of new Clinical Research Group employees as well as ongoing training of current staff regarding clinical trial execution
- Provides protocol related inservices to professional and ancillary staff in outpatient and inpatient settings, as needed
- Participates as a speaker in departmental in-services, trainings and meetings, as needed
- Serves as a resource for research personnel regarding protocol and compliance information
Bachelor's degree. Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience. It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html