MD Anderson Cancer Center Coordinator, Clinical Research Program - Investigational Cancer Therapeutics in Houston, Texas
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.
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.
- 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).
- 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.
- 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.
- Other duties as assigned.
Required: Bachelor's degree.
Preferred: Master's degree
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.
Preferred: Experience with Clinical Research Protocols.
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: 141465
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: No
Minimum Salary: US Dollar (USD) 50,800
Midpoint Salary: US Dollar (USD) 63,500
Maximum Salary : US Dollar (USD) 76,200
Science Jobs: No