The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education, and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.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.KEY FUNCTIONS1. 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.
Proo 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.4. Other duties as assigned.The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the department/program and take the initiative in making decisions and taking actions to further these goals.The above functions require the following abilities and skills:· Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with patients and co-workers.· Strong attention to detail. Ability to focus on task is essential.· Strong organizational skills.· Ability to work with personal computers using standard word processing software, spreadsheets, and programs for database and graphics usage. Must be able to compare database and file material on an ongoing basis.· Requires use of computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button, multiple line telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)· Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis.· Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information.· Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.EDUCATIONRequired: Bachelor's degree.Preferred: Master's degree.EXPERIENCERequired: 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.htmlAdditional Information
Requisition ID: 170063
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 55,500
Midpoint Salary: US Dollar (USD) 69,500
Maximum Salary : US Dollar (USD) 83,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Remote
Pivotal Position: Yes
Referral Bonus Available?: No
Relocation Assistance Available?: Yes
Science Jobs: No
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