Research Data Specialist - Leukemia
- Requisition #: 170717
- Department: Leukemia
- Location: Houston, TX
- Posted Date: 10/2/2024
The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education, and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.
KEY FUNCTIONS
Responsible for the preparation of accurate and detailed instructions for all clinical research sampling required by Leukemia Department protocols and which involve the effort and commitment of the Leukemia Clinical Research Services laboratory.
Clinical Trial-Specific Sampling Instructions
· For designated protocols, provides schematic solutions for effective protocol research sample collection, processing and shipment to sponsor-designated labs across the nation and worldwide.
· Develops SOPs for key processes and procedures for the effective management of clinical trial sampling.
· Manages new protocol start-up process as required. 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 protocol requirements.
· Creates collection orders in accordance with protocol requirements.
· Develops and maintains a tracking system for monitoring revisions and amendments to protocols and revise LCRS draw sheets accordingly and in a timely fashion.
· Must be able to read and understand complex protocol documents, instructions from sponsor or PI, and the lab manual produced by the sponsor.
Query Resolution
· Addresses 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.
· Collaborates with study manager, study PI, lab supervisor and lab manager in preparing LCRS response and resolution to queries.
· Supervises audits of LCRS services performed by FDA, IND office or sponsor.
· Tracks query resolution and ensures that all assigned queries are resolved for all LCRS details.
· 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.
Quality Control
· Participates in the review of draw sheet instructions prepared by others in the research team to ensure that protocol specific details are consistent with the study documents.
· Review the daily completed draw sheets to ensure that they are correct and consistent with the study design.
· Reviews the next day scheduled draws to ensure that relevant draw sheets are prepared and are correct. Notes when amendment revisions have been overlooked and makes the needed corrections.
· Supervises audits of LCRS services performed by FDA, IND office or sponsor.
· Tracking and logging of lab specimens.
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: Demonstrate strong problem-solving skills, particularly in addressing data discrepancies, resolving missing information, and correcting protocol deviations in a timely manner. Proficiency in Clinical Data Management Systems (CDMS), including platforms such as REDCap, Medidata, Oracle Clinical, or other electronic data capture (EDC) systems. A solid understanding of clinical trial regulations, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, as well as regulatory requirements from the FDA and EMA, is essential. Additionally, knowledge of data privacy regulations, such as HIPAA, is required. Keen attention to detail, ensuring the accuracy, validation, and error-free management of data throughout the clinical trial process.
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
#LI-Hybrid
KEY FUNCTIONS
Responsible for the preparation of accurate and detailed instructions for all clinical research sampling required by Leukemia Department protocols and which involve the effort and commitment of the Leukemia Clinical Research Services laboratory.
Clinical Trial-Specific Sampling Instructions
· For designated protocols, provides schematic solutions for effective protocol research sample collection, processing and shipment to sponsor-designated labs across the nation and worldwide.
· Develops SOPs for key processes and procedures for the effective management of clinical trial sampling.
· Manages new protocol start-up process as required. 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 protocol requirements.
· Creates collection orders in accordance with protocol requirements.
· Develops and maintains a tracking system for monitoring revisions and amendments to protocols and revise LCRS draw sheets accordingly and in a timely fashion.
· Must be able to read and understand complex protocol documents, instructions from sponsor or PI, and the lab manual produced by the sponsor.
Query Resolution
· Addresses 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.
· Collaborates with study manager, study PI, lab supervisor and lab manager in preparing LCRS response and resolution to queries.
· Supervises audits of LCRS services performed by FDA, IND office or sponsor.
· Tracks query resolution and ensures that all assigned queries are resolved for all LCRS details.
· 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.
Quality Control
· Participates in the review of draw sheet instructions prepared by others in the research team to ensure that protocol specific details are consistent with the study documents.
· Review the daily completed draw sheets to ensure that they are correct and consistent with the study design.
· Reviews the next day scheduled draws to ensure that relevant draw sheets are prepared and are correct. Notes when amendment revisions have been overlooked and makes the needed corrections.
· Supervises audits of LCRS services performed by FDA, IND office or sponsor.
· Tracking and logging of lab specimens.
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: Demonstrate strong problem-solving skills, particularly in addressing data discrepancies, resolving missing information, and correcting protocol deviations in a timely manner. Proficiency in Clinical Data Management Systems (CDMS), including platforms such as REDCap, Medidata, Oracle Clinical, or other electronic data capture (EDC) systems. A solid understanding of clinical trial regulations, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, as well as regulatory requirements from the FDA and EMA, is essential. Additionally, knowledge of data privacy regulations, such as HIPAA, is required. Keen attention to detail, ensuring the accuracy, validation, and error-free management of data throughout the clinical trial process.
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: 170717
- 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: Hybrid Onsite/Remote
- Pivotal Position: Yes
- Referral Bonus Available?: No
- Relocation Assistance Available?: Yes
- Science Jobs: No
#LI-Hybrid
