The primary purpose of the Research Data Specialist position is collaboration with the research team and principal investigator in conduct of large-scale multi-protocol, multi institutional, clinical trial projects. Assists with project oversight by assuring protocol compliance, data integrity, and communication of pertinent protocol information. Provides training and orientation of new research staff.

JOB SPECIFIC COMPETENCIES:

Data entry, analysis, and reporting
* Work with multiple Principal Investigator teams to perform accurate and timely capture of subject information in various research systems.
* Serve as a subject matter expert to the departmental Research Data team.
* Transfer patient information into the electronic databases and act as lead for ensuring maintenance of accurate data entry.
* Review medical records to extract data points.
* Develop and maintain systems; protocol-specific tools, such as eCRF; 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.

Quality assurance and process improvement for clinical research projects:
* Work closely with the study team to ensure consistency between protocol database and source documentation. Perform source document verification for protocol compliance and drug accountability.
* Coordinate meetings with the Principal Investigator and research team to review study status. Generate research reports to support Investigator's research oversight.
* Coordinate routine monitoring visits with internal and industry representatives. Act as a lead during deadlines, routine and for-cause audits. Provide sufficient, appropriate and timely responses to verbal and written queries.
* Conduct internal clinical trial monitoring in accordance with departmental and institutional policies and procedures.
* Participate in departmental clinical research quality assurance initiatives. Review clinical trial documents for consistency, logistics and implementation.
* Analyze workflow and processes, design and execute improvements to meet team goals, ensure efficiency and effectiveness.

Research education and training
* Onboard, orient, mentor and train Research Data staff, including new hire employees. Serve as an overall resource to departmental research personnel regarding clinical trial conduct.
* Assign and monitor mentor/mentee relationships for training.
* Communicate with the Principal Investigator and study team regarding upcoming deadlines, research and protocol meetings, and other pertinent information.
* Identify training gaps or opportunities for knowledge sharing with individuals and/or groups.
* Develop and provide educational presentations for training meetings.

Administrative research functions and activities
* Participate in all aspects of the clinical trial process from study startup to closeout.
* Assist Research Data Supervisor with assigning and evaluating clinical trial workload.
* Assist with department efforts to preserve and improve performance including, but not limited to, financial reconciliation, regulatory compliance, and departmental IT initiatives.
* Provide data and information related to, and assist in writing, protocols, grants, abstracts, manuscript submissions, and Principal Investigator projects as needed.
* Communicate verbally and in writing, as needed or as requested by Principal Investigator and/or Research Data Supervisor, with internal reviewers or external agencies (e.g., pharmaceutical sponsors and their representatives and/or governmental study sponsors, such as National Cancer Institute or Food and Drug.

EDUCATION:
Required: Bachelor's degree in a related field.

Preferred: Master's degree in a related field.

EXPERIENCE:
Required: Two years research study experience. May substitute required education degree with additional years of equivalent experience. With preferred degree, no experience required.

Preferred: Data Entry and Data Analysis.

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: 172146 Employment Status: Full-Time Employee Status: Regular Work Week: Day/Evening Minimum Salary: US Dollar (USD) 48,000 Midpoint Salary: US Dollar (USD) 60,000 Maximum Salary : US Dollar (USD) 72,000 FLSA: exempt and not 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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