The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
Bringing the most exciting new agents for cancer treatment more quickly from the laboratory to clinical trials is the goal of MD Anderson's Phase I Clinical Trials Program in the Department of Investigational Cancer Therapeutics. The program is a centralized resource for physician-scientists throughout the institution and community physicians looking for clinical trials for their patients with advanced cancer. The Phase I Clinical Trials Program is leading multi-disciplinary, first-in-man studies that include multiple tumor types in a single study.
The primary purpose of the Coordinator, Clinical Research Program position is to provide administrative services for the coordination of phase I research studies, sponsored agreements and contracts. Provides administrative support and guidance, and research project management services for the department. This position exercises considerable discretion in the implementation and reporting of research activities within the program and is integral to the daily provision of services provided to both faculty and administrative agents of the institution.
1. Protocol development/activation
- Develop and maintain knowledge of institutional protocol submission procedures and requirements.
- Maintain a processing and tracking system for all protocol related paperwork.
- Collect and develop criteria information for protocol submission.
- Submit FReD checklist and other compliance documents for clinical trial agreement review, negotiation, and execution.
- Interact with appropriate institutional staff to ensure that the protocol approval process is completed in a timely manner.
- Keep the PI informed of issues with the protocol approval or clinical trial agreement negotiations.
- Interact with staff in VP Office for Research Administration for issues related to INDs that the institution will hold as the sponsor.
- Attend planning meetings, such as site initiation visits (SIVs).
2. Protocol administration/maintenance
- Coordinate regulatory correspondence.
- Communicate verbally and in writing, as needed or as requested by the principal investigator of the study with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
- Complete forms and comply with institutional, state, and federal agency requirements; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.
- Work with staff in Patient Business Services to develop research charge tickets for protocols.
- Interact with appropriate institutional staff for amendments to clinical trials.
Coordinate FDA submissions and participate in research audits, as required.
3. Data collection and reporting
- Provide assistance in the preparation of technical reports, abstracts, slide presentations, spreadsheets, posters, and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals, as assigned.
- Copyedit technical reports.
- Proofread galley proofs of manuscripts nearing publication.
- Review protocol documents including abstracts, text and informed consent for relevant information.
- Interact with NCI and pharmaceutical industry to correct/update protocol documents.
This position requires:
Working in Office Environment
Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)
Exposure to human/animal blood, body fluids, or tissues
Exposure to harmful chemicals
Exposure to radiation
Exposure to animals
Indicate the time required to do each of the following physical demands:
Up to 10 lbs
10lbs to 50 lbs
More than 50 lbs
Up to 10 lbs
10lbs to 50 lbs
More than 50 lbs
Master's degree or PhD.
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.
Research Regulatory 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
non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
US Dollar (USD) 50,800
US Dollar (USD) 63,500
Maximum Salary :
US Dollar (USD) 76,200