Coordinator, Clinical Studies (Clinical Research Data) - Genitourinary Medical Oncology
MD Anderson Cancer Center
Houston, TX, United States
Posted about 5 days agoExpires on August 13, 2019
Coordinator, Clinical Studies - Genitourinary Medical Oncology
The mission of the Department of Genitourinary Medical Oncology is to reduce the morbidity and mortality of genitourinary cancers for the benefit of our patients and for future generations.
Our clinical care is based on research into the biology of genitourinary tumors. With a clearer understanding of the biologic behavior of genes, molecules, and cells that are responsible for the formation and growth of these tumors, we have been able to develop treatments tailored to the individual patient. The Department of Genitourinary Medical Oncology is at the leading edge of research to identify important biologic markers to help us determine which patients are at greatest risk of advanced disease and metastasis.
These powerful tools combined with the use of innovative therapeutic agents will increase survival and promote a better quality of life for patients with genitourinary cancers.
The Department has created an interactive environment in which ideas are freely exchanged among basic science, translational, and clinical investigators in the Genitourinary Cancer Center, the David H. Koch Center for Applied Research of Genitourinary Cancers, throughout the institution, and around the world.
Critical to the success of the Department of Genitourinary Medical Oncology is the education of young clinicians and investigators who will build on the foundation of our work and ensure continued meaningful contributions to the treatment, prevention, and research of genitourinary cancers.
Designs, implements, monitors, and reports on clinical research project st atus, ensuring on-time performance (30%)
Reads protocol and helps develops systems for screening and scheduling patients. Develops on-study notes and other documents as needed for protocols with patient care team members
Responsible for accurate and timely transcription of study data to trial Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires ability to gather relevant information and determine the appropriate information to report. Responsible for tracking return visit time points per protocol, tracing and recording.
Responsible for tracking and recording deviations, violations, adverse events and other study related activities.
Knowledge of protocol databases and tools: CRF, CORe, GURU, Microsoft office, Excel, and others as designated.
Consults with PI and the Research Nurse Supervisor (RNS) regarding ongoing study assignments. Collaborates with other members of the multidisciplinary team (research nurses, lab staff, and clinic personnel) as necessary.
Works with PI and fellow team members to develop recommendations on amendments to the protocol that will improve protocol execution.
Ensure all required regulatory documentation for the trial is completed and stored per department policy.
Assists in analysis and quality assurance of clinical research information (20%)
Coordinates routine monitoring and audits with industry sponsor pharmaceutical representative or clinical research organizations. Provides sufficient, appropriate, and timely responses to sponsor, MDACC IND and written queries.
Assists with training staff for MDACC IND studies to consist of generating reports from databases for pertinent reports
In conjunction with the Supervisor Clinical Studies, conducts routine monitoring per departmental quality assurance Standard Operating Procedures (SOP) for multicenter studies when GU Medical Oncology is the lead institution.
Will perform quality assurance on Non Investigator Initiated Trials to ensure quality data.
Provides support and leadership for research staff peers: an education and training element within the department (10%)
Trains and/or orients Coordinators of Research Data, Sr. Research Data Coordinators, Research Data Specialist and Research Nurses to the department and to clinical research procedures/processes.
Serves as a resource for research personnel regarding protocols and compliance informational
Communicates with the PI, research nurse and others regarding upcoming deadlines, research and protocol meetings, and other pertinent information.
Assists with Administrative Research Functions (20%)
In consultation with the research nurse and PI, completes and submits Continuing Reviews, Investigational New Drug (IND) reports, sponsor and other required reports in a timely manner.
Participates in protocol start up meetings and close-out visits.
Participates in the development of policies, procedures, and work flow processes to ensure project efficiency and effectiveness.
Communicates in a manner that fosters a positive, productive environment (20%)
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.
Must be able to independently initiate weekly assignments without supervision.
He/she must be able to understand and respond to telephone conversations with physicians and other members of the health care team, both within and outside the institution. He/she must have excellent verbal and written communication skills.
Advocate for the clinical research process per institutional, divisional, and departmental SOPs in keeping with Good Clinical Practice for research.
Other duties as assigned
Education Required: Bachelor's degree.
Experience Required: 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
Requisition ID: 126877
Employment Status: Full-Time
Employee Status: Regular
FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
Work Week: Days
Fund Type: Soft
Pivotal Position: Yes
Minimum Salary: US Dollar (USD) 50,800
Midpoint Salary: US Dollar (USD) 63,500
Maximum Salary : US Dollar (USD) 76,200