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.

Under the supervision of the Clinical Protocol Admin Mgr. assists the faculty investigator in the overall conduct of the clinical trials assigned maintaining adherence to the protocol, including but not limited to:

· assists with protocol and consent revisions as needed,

· assists with the IRB submission process as needed,

· actively participates in protocol meetings, such as investigator and initiation meetings.

· manages protocols at appropriate intervals and participates in monitoring and audit activities.

· Appropriately submits information regarding adverse events to the IRB & sponsor EDCs

· coordinates, evaluates, and documents patient participation in clinical trials.

Effectively follows patients on protocol by maintaining knowledge of their adverse events and response to treatment.

Appropriately documents findings in the medical record in collaboration with physicians, mid-level providers, research nurses, and data managers.

Contributes in the department of ID/IC/EH protocol review and submission process and attend protocols meetings.

Manages protocols at appropriate intervals and participates in monitoring and audit activities. Ensures that the conduction of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies. Develops and maintains systems for the coding, editing, and computer entry of data for assigned research studies focusing on continuous patient follow-up. Designs and maintains research databases for the department and institutional databases for various research studies.

Spends 50% or more time in direct patient contact. Obtains patient consenting for minimal risk studies. Follows-up protocol submission about research investigations, laboratory tests and responses .

Assists the faculty investigator in data file preparation and attends data review meetings as required by the department. Prepares specific protocol reports and analysis and assist in continuing reviews and eSRC submissions.

Participates and ensures prospective data collection is entered in a timely manner into the departmental database and/or study CRF/eCRF.

Attends departmental meetings as required. Attends research team meetings.

Duties may also include collection and processing of specimens. Coordinates the acquisition of research blood and other samples. Manages, and orders the consumable lab supplies necessary to meet protocol requirements for research specimens.

Other duties as required.

EDUCATION: Bachelor's degree.

EXPERIENCE: 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

Additional Information

• Requisition ID: 167848

• 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: Hybrid Onsite/Remote

• Pivotal Position: No

• Referral Bonus Available?: No

• Relocation Assistance Available?: No

• Science Jobs: No

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