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Sr. Clinical Studies Coordinator - Sarcoma Medical Oncology
SUMMARY
The Sr. Clinical Studies Coordinator performs all of the functions of a Clinical Studies Coordinator. In addition:
- Responsible for the overall effective operation of designated protocols to include development, design and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.
- Trains other support staff in study coordination to include providing training and guidance with regard to the policies and procedures that are related to conduct of clinical trials; planning, designing and conducting complex professional and ancillary staff education sessions to ensure protocol compliance and dissemination of new information and policies.
- Coordinates FDA submissions and supervises clinical trials audits.
- Performs QA audits to monitor compliance and accuracy of data.
- Compiles protocol data for manuscript submission.
- Assists with supervisory functions, participates in the evaluation process.
The ideal candidate will have a clinical research certification such as: Society of Clinical Research Associates (SOCRA) certification or CCRC (Certified Clinical Research Coordinator).
JOB SPECIFIC COMPETENCIES
- Clinical Trial management consisting of eligibility review, patient enrollment, clinical management while on trial, data collection and submission to sponsor, lab tracking, SAE reporting, query resolution, and audit responsibility.
- Verification of sample collection and appropriate storage of specimens.
- Specimen shipping
- Maintenance of a specimen tracking system once samples are shipped.
Other duties as assigned.
EDUCATION
Required: Bachelor's degree.
Preferred: Master’s degree.
EXPERIENCE
Required: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. With preferred degree, three years of required experience. May substitute required education degree with additional years of equivalent experience on a one to one basis.
Onsite Presence: Is Required
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
