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Senior Research Data Coordinator
The primary purpose of the Senior Research Data Coordinator position is to provide administrative and patient care services for the coordination of research studies. Supports coordinating staff and external research personnel for successful study conduct. Serves as a mentor to departmental staff.
What We Offer?
* Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&D, and disability insurance.
* Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.
* Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.
* Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.
JOB-SPECIFIC COMPETENCIES:
Data Management (30%)
* Act as a lead for data entry and transfer of patient information into electronic databases on multiple clinical research studies.
* Proactively manage clinical research data processes including, but not limited to, rapid patient accrual on Phase 1-2, multi-arm, clinical research trials.
* Review medical records to extract data points.
* Collect, store and maintain accurate and up-to-date source documentation to support data entry.
* Meet contractual agreements for data entry and query resolution timelines; meet external deadlines to support protocol milestones.
* Develop and maintain systems; protocol-specific tools, such as case report forms; and other study materials to control the data flow for single-institution and/or multi-center projects.
* Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the institutional policies and department training.
* Professional Expertise and Credibility through Educational Programs/Training and Mentoring of New Staff (25%)
* Mentor and train Research Data staff, including new hire employees. Serve as an overall resource to research data personnel regarding clinical trial conduct.
* Acclimate new hires to institutional Core Values, competencies and job-specific competencies.
* Identify opportunities for individual and/or group training; update departmental training documents and workflows; and contribute to improving training initiatives.
* Continuously seek learning opportunities and supplemental education.
* Support and participate in departmental initiatives.
Clinical Research Support (25%)
* Reconcile electronic medical records and source documentation to facilitate accurate patient data reporting consistent with institutional, industry and government standards.
* Maintain clinical trial documents for regulatory compliance.
* Coordinate and prepare weekly updates for protocol review.
* Meet with the Principal Investigator and study team routinely to review study status.
* Alert appropriate individuals regarding upcoming deadlines, meetings, audits, etc. and lead team preparation for these events.
* Communicate verbally and in-writing with internal and external collaborators to meet study objectives.
Host External Research Personnel (15%)
* Facilitate external research personnel vetting process to comply with institutional and HIPAA requirements.
* Troubleshoot vetting and access issues for department External Research Monitors.
* Coordinate routine monitoring visits with internal and industry representatives.
* Collaborate with external departments for source document verification.
* Act as a lead contact for protocol data to answer questions and problem solve on an individual and team level. Provide sufficient, appropriate and timely responses to verbal and written queries.
* Lead deadlines, routine and for-cause audits.
Other Duties as Assigned (5%)
Working Conditions:
* Deadlines - Work environment is deadline focused on the time or date in which a particular task must be finished or a particular assignment, task or function must be done.
* Sedentary Environment - Worker will spend majority of time seated at workstation (frequent 34-66%).
EDUCATION:
Required: High School Diploma or Equivalent.
Preferred: Bachelor's Degree
EXPERIENCE:
Required: Four years related experience. No experience required with preferred degree.
Preferred: Two years of experience in research data entry.
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.
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
