Job description

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.

This position will oversee the planning and execution of multi site clinical studies from initial conception, study start through study closure.

JOB SPECIFIC COMPETENCIES

Oversees all aspects of clinical trial start-up and management including project planning and internal/external collaborations with multidisciplinary teams to ensure successful execution of the clinical trial.
Serves as primary liaison for study sites, sponsors and internal departments.
Establishes and tracks start-up timelines and appropriate performance metrics. Notifies stakeholders of delays.
Coordinates and aligns the needs of multiple stakeholders and drives the study through local approval procedures to obtain approval within a reasonable time frame.
Tracks items related to CDAs, budget and contract completion status.
Schedules, coordinates, and participates in internal feasibility meetings, press-site visits, site initiation visits and project meetings.
Ensures regulatory compliance of study sites to site standard operating procedures, FDA/GCP regulations and ICH guidelines.
Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
Ensures clinical investigators/potential investigators and study sites can meet study requirements.
Oversees data collection and documentation activities; queries databases and prepares reports; manages compliance documents.

Other duties as assigned

Education

Required: Bachelor's Degree Biology, Chemistry, Business Administration, Healthcare Administration or related field.

Preferred Education: Master's Degree Biology, Chemistry, Business Administration, Healthcare Administration or related field.

Experience

Required: 5 years Clinical study management experience or equivalent healthcare compliance experience to include prior experience with oncology drug trials, and experience with FDA regulations and ICH/GCP. Experience with Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project, Visio).

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