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The Research Data Specialist collaborates with the LCRS management and operations teams, inventory team, study managers and principal investigator to provide an of both research and patient care services and operational management for clinical trials. Impacts the efficient analysis and timely processing of research protocols and contributes to the care of patients enrolled in designated protocols. Assures quality in carrying out clinical research protocols through the education of Coordinators, Clinical Studies (CCSs), the LCRS technical staff and supervisors as to protocol requirements and institutional guidelines for compliance. Ensures strict adherence to the policies and procedures of the institution. Impacts the successful conduct of research clinical trials, the appropriate evaluation and reporting of these trials, and the reputation of the PI, the department, and the cancer center as a center of excellence for patient-oriented research.

*The ideal candidate will have basic research knowledge, read/review protocols and lab manuals, and lab budget development. Knowledge of MS office, Excel, Access. Be able to develop tracking systems databases for various processes*

JOB SPECIFIC COMPETENCIES

LCRS Drawsheet Development:

• Responsible for the development of protocol specific draw sheet production which provides detailed instructions for LCRS clinical sampling. Learn to translate protocol sampling and the laboratory manual provided by the PI and/or sponsors. This includes the development, design and resolution of operational issues in collaboration with the principal investigator, study manager and study sponsor.

• For assigned protocols, provides instructions for effective protocol research sample collection, processing and shipment to internal labs or sponsor-designated labs across the nation and worldwide.

• Participates in site initiation visits (SIV), audits and monitor visits, obtains clarification of outstanding issues related to sample collection, processing and shipment, and captures all the information addressed in draw sheets and team presentations.

• Collaborates with study sponsors to ensure lab manuals are developed correctly and are in compliance with the protocol and lab capabilities.

• In a pre-activation meeting, reviews new studies with the LCRS technical team, provides an overview of each study, overall design, and schedule of research assessments.

• Collaborates with department study management staff and study chair or protocol sponsor regarding protocol amendments.

• Develops and maintains a tracking system for monitoring revisions and amendments to protocols and revise LCRS draw sheet accordingly and timely.

• Incorporate revisions in the collection sheets and notify the LCRS team that amended draw sheet is available.

• Requires considerable exercise of independent judgment, initiative, and a basic knowledge of medical terminology and administrative procedures.

• Scan newly designed draw sheets into QB so that the document is ready for use in the sample collection lab. Revise amended draw sheets should also be scanned into QB to replace previous versions.

LCRS Budget Development:

• Starting with the CRF coverage analysis, review same and ensure that the coverage analysis includes all required EKG testing timepoints dictated by the protocol.

• Prepare a draft LCRS budget for all samples that are going to local or central labs based on the number of cycles and patients for all timepoints.

• Work closely with the Leukemia contracts and budgets teams to verify budget development at various times throughout budget and draw sheet development.

• Collect lab manual and all other required documents to compile a completed folder of material provided for the study.

• Proofread and review the draw sheet to ensure that it is sufficiently explicit for development of a budget document.

• Assist LCRS manager in creating lab budget for sponsor and grant related clinical trials. The lab budget will encompass a budget summary and sampling schedule.

• Manages industry sponsor relations on behalf of LCRS and the Leukemia Department. Interacts with study sponsors and acts as a liaison between sponsor representatives and the laboratory team.

• Performs QA audits to monitor compliance and accuracy of data.

• Manages sponsor queries related to all aspects of research sample collection, processing and shipment on study protocols, including accuracy of time points and quality of final product. Follows through and ensures the resolution of queries in a timely manner and to mutual satisfaction. Maintain a query database of all the queries received from industry sponsors such as ECG, bone marrow, PK, blood samples, urine, and so forth.

Data Tracking:

• Provide a continuous query of missing lab manuals and other needed material, including follow up with sponsors. Continuously look for missing lab manual and other material to ensure it is part of the protocol folder.

• Develop tracking system database for all issues and problems which develop during the protocol budget and drawsheet design process.

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: Basic research knowledge, read/review protocols and lab manuals, and lab budget development. Knowledge of MS office, Excel, Access. Be able to develop tracking systems databases for various processes.

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: 171857

• Employment Status: Full-Time

• Employee Status: Regular

• Work Week: Days

• 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: Remote

• Pivotal Position: No

• Referral Bonus Available?: No

• Relocation Assistance Available?: No

• Science Jobs: No

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