Clinical Trial Activation Specialist - Clinical Trials Start-Up
- Employer
- University of Texas MD Anderson Cancer Center
- Location
- Houston, Texas
- Salary
- Competitive
- Closing date
- Dec 3, 2024
View more categoriesView less categories
- Discipline
- Health Sciences
- Organization Type
- Healthcare/Hospital
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Job Details
The mission of The University of Texas MD 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.
Oversees the clinical trial activation process at MD Anderson. Acts as a liaison between different central departments and research teams throughout the lifecycles of the clinical study. Maintains real-time tracking of the progress and milestones of assigned trials and proactively alerts to potential delays. Responsible for confirming all institutional requirements are met prior to activation/implementation
JOB SPECIFIC COMPETENCIES
60% Activations/Modifications Support
· Provides administrative support including modification implementation for clinical research protocols.
· Responsible for the overall effective operation of protocols which involve the collaboration with clinical research administration, departments, and all central offices.
· Manages study modifications and implementation after confirming all institutional requirements are met.
· Develops and maintains a tracking system for monitoring activations and modifications.
20%Communication
· Serves as a liaison between central offices and research staff during the life cycle of a protocol to navigate protocols through the clinical research systems.
· Prepares for and attends clinical department meetings for assigned studies.
20% Maintenance of Written Regulatory and other documentation
Assures appropriate documentation and standard operating procedures are maintained. Maintains up to date knowledge of institutional databases for execution of clinical trial workflow such as OneIRB, OnCore, ServiceNow, RCTS, and others as indicated.
Other duties as assigned.
Education
Required: Bachelor's degree.
Preferred: Master's degree.
Experience
Required: Five years related experience to include three years program management experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred: Experience in a regulatory position reading protocols, making modifications.
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
Oversees the clinical trial activation process at MD Anderson. Acts as a liaison between different central departments and research teams throughout the lifecycles of the clinical study. Maintains real-time tracking of the progress and milestones of assigned trials and proactively alerts to potential delays. Responsible for confirming all institutional requirements are met prior to activation/implementation
JOB SPECIFIC COMPETENCIES
60% Activations/Modifications Support
· Provides administrative support including modification implementation for clinical research protocols.
· Responsible for the overall effective operation of protocols which involve the collaboration with clinical research administration, departments, and all central offices.
· Manages study modifications and implementation after confirming all institutional requirements are met.
· Develops and maintains a tracking system for monitoring activations and modifications.
20%Communication
· Serves as a liaison between central offices and research staff during the life cycle of a protocol to navigate protocols through the clinical research systems.
· Prepares for and attends clinical department meetings for assigned studies.
20% Maintenance of Written Regulatory and other documentation
Assures appropriate documentation and standard operating procedures are maintained. Maintains up to date knowledge of institutional databases for execution of clinical trial workflow such as OneIRB, OnCore, ServiceNow, RCTS, and others as indicated.
Other duties as assigned.
Education
Required: Bachelor's degree.
Preferred: Master's degree.
Experience
Required: Five years related experience to include three years program management experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience.
Preferred: Experience in a regulatory position reading protocols, making modifications.
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
Company
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 2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
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