Senior Research Data Coordinator - Gynecologic Oncology & Reproductive Medicine
- Requisition #: 171987
- Department: Gyn Onc & Reproductive Med
- Location: Houston, TX
- Posted Date: 12/5/2024
SUMMARY
The primary purpose of the Senior Research Data Coordinator for the Department of Gynecologic Oncology & Reproductive Medicine is to serve as a lead in data management, administration and patient care services for the coordination of research studies conducted by the Developmental Therapeutics Program. Provides/manages the accurate collection, verification, and management of protocol-required data. The position requires the ability to work independently with limited supervision, to establish priorities, manage multiple tasks, complete work assignments in an accurate and timely fashion and to comprehend the goals of the department and program.
Research Data Management
Maintains knowledge of protocol specific guidelines and general procedures for data management practices for research protocols. Assists in the development and maintenance of a system for collecting protocol data including but not limited to records of surgery, therapy dates, laboratory results, and pathology information. Abstracts and collects patient data from electronic health record and other relevant source documents. Enters research study data into electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines. Monitors and records in relevant systems outside laboratory data for protocol patients and ensures PI and research nurse are notified in a timely fashion. Performs ongoing and concurrent review of data to ensure completeness and accuracy. Addresses data entry omissions or inconsistencies and amends errors in a timely manner. Communicates research data revision requests to the physician and/or clinical research staff for correction. Trains other members of research staff on database utilization and management. Creates and maintains system to organize and file protocol data including but not limited to records of study eligibility, pathology reports and specimens for review/confirmation, surgery reports, therapy dates, laboratory results, and follow up information. Maintains telephone contact with other institutions participating in studies and collects data as assigned.
Protocol Administration Responsibilities
Ensures the conduction of assigned clinical trials is in accordance with Good Clinical Practice guidelines, federal regulations, institutional and departmental policies and procedures. Reviews new protocols for data management requirements. Assists in development of laboratory manual and specimen handling, processing, and storage pathways as assigned. Participates in Site Initiation Visits (SIVs), conference calls and protocol meetings. Schedules and performs start-up meetings with multi-center research staff and/or participating sites on specific data or biospecimen-related roles and tasks. Schedules internal and external auditor/monitor visits for team. Assists with annual reviews, updates, and response data, and generates reports as requested. Assists with data compilation for the preparation of information and reports for manuscript/grant submission. Collaborates with physician, study team, and departmental protocol administration team to complete financial and regulatory tasks as assigned. Contributes to milestone logs of patient activity to assist in hospital account reconciliation and to facilitate compensation from sponsors of clinical trials as assigned.
Protocol Patient Management
Assist research nurses and other clinical research personnel with patient-related activities including screening, ordering tests, collecting specimens and study documentation of patient reported outcomes as assigned. Conducts structured interviews with research subjects for protocol data collection. Assists with follow-up appointments and provides telephone reminders to patients. Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations. Screens medical record to identify potential study subjects and collaborates with research nurse team member and or study PI regarding subject eligibility questions. Develops and maintains a detailing screening log as well as patient tracking systems. Participates in the informed consent process for minimal-risk studies, as assigned, and registers subjects utilizing the institutional clinical trial management system according to institutional policy. Documents study specific information appropriately in the patient medical record.
Assists in retrieval of pathology slides/blocks and mail as specified in protocols. Assists in transportation of blood/tissue specimens between the labs, and clinic as needed by protocol. Collects, processes, stores, and ships blood, tissue, and other body fluid specimens according to institutional and protocol specific guidelines.
Other responsibilities as assigned.
Interacts with members of interdisciplinary team inter and intra-departmentally to obtain pertinent information and verify the status of ongoing projects. Verbal, telephone, email and written communications are timely and intent is clearly communicated with institutional and other personnel.
Other duties as assigned
Onsite Presence: Hybrid On-site/Remote
WORKING CONDITIONS
PHYSICAL DEMANDS
Required Education:
High school diploma or equivalent.
Preferred Education:
Bachelor's degree
Required Experience:
Four years of related experience. With preferred degree, no experience required.
Preferred Experience:
Oncology treatment trials data entry such as adverse events, SAE's (serious adverse events) and treatment, research data management, current or past experience being in a Research Data Coordinator role, biospecimen coordination (handling/processing/storing/shipping), monitoring visit coordination with CROs or IND office, experience with Epic.
Work Schedule:
4 days a week onsite during orientation and 3 days a week thereafter.
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
The primary purpose of the Senior Research Data Coordinator for the Department of Gynecologic Oncology & Reproductive Medicine is to serve as a lead in data management, administration and patient care services for the coordination of research studies conducted by the Developmental Therapeutics Program. Provides/manages the accurate collection, verification, and management of protocol-required data. The position requires the ability to work independently with limited supervision, to establish priorities, manage multiple tasks, complete work assignments in an accurate and timely fashion and to comprehend the goals of the department and program.
Research Data Management
Maintains knowledge of protocol specific guidelines and general procedures for data management practices for research protocols. Assists in the development and maintenance of a system for collecting protocol data including but not limited to records of surgery, therapy dates, laboratory results, and pathology information. Abstracts and collects patient data from electronic health record and other relevant source documents. Enters research study data into electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental timelines. Monitors and records in relevant systems outside laboratory data for protocol patients and ensures PI and research nurse are notified in a timely fashion. Performs ongoing and concurrent review of data to ensure completeness and accuracy. Addresses data entry omissions or inconsistencies and amends errors in a timely manner. Communicates research data revision requests to the physician and/or clinical research staff for correction. Trains other members of research staff on database utilization and management. Creates and maintains system to organize and file protocol data including but not limited to records of study eligibility, pathology reports and specimens for review/confirmation, surgery reports, therapy dates, laboratory results, and follow up information. Maintains telephone contact with other institutions participating in studies and collects data as assigned.
Protocol Administration Responsibilities
Ensures the conduction of assigned clinical trials is in accordance with Good Clinical Practice guidelines, federal regulations, institutional and departmental policies and procedures. Reviews new protocols for data management requirements. Assists in development of laboratory manual and specimen handling, processing, and storage pathways as assigned. Participates in Site Initiation Visits (SIVs), conference calls and protocol meetings. Schedules and performs start-up meetings with multi-center research staff and/or participating sites on specific data or biospecimen-related roles and tasks. Schedules internal and external auditor/monitor visits for team. Assists with annual reviews, updates, and response data, and generates reports as requested. Assists with data compilation for the preparation of information and reports for manuscript/grant submission. Collaborates with physician, study team, and departmental protocol administration team to complete financial and regulatory tasks as assigned. Contributes to milestone logs of patient activity to assist in hospital account reconciliation and to facilitate compensation from sponsors of clinical trials as assigned.
Protocol Patient Management
Assist research nurses and other clinical research personnel with patient-related activities including screening, ordering tests, collecting specimens and study documentation of patient reported outcomes as assigned. Conducts structured interviews with research subjects for protocol data collection. Assists with follow-up appointments and provides telephone reminders to patients. Coordinates with research staff to identify and address any study-related issues, including but not limited to inadequate or missing source documentation, adverse event reporting and protocol deviations or violations. Screens medical record to identify potential study subjects and collaborates with research nurse team member and or study PI regarding subject eligibility questions. Develops and maintains a detailing screening log as well as patient tracking systems. Participates in the informed consent process for minimal-risk studies, as assigned, and registers subjects utilizing the institutional clinical trial management system according to institutional policy. Documents study specific information appropriately in the patient medical record.
Assists in retrieval of pathology slides/blocks and mail as specified in protocols. Assists in transportation of blood/tissue specimens between the labs, and clinic as needed by protocol. Collects, processes, stores, and ships blood, tissue, and other body fluid specimens according to institutional and protocol specific guidelines.
Other responsibilities as assigned.
Interacts with members of interdisciplinary team inter and intra-departmentally to obtain pertinent information and verify the status of ongoing projects. Verbal, telephone, email and written communications are timely and intent is clearly communicated with institutional and other personnel.
Other duties as assigned
Onsite Presence: Hybrid On-site/Remote
WORKING CONDITIONS
| | Frequency |
| Deadlines Exposure to blood, bodily fluids, and/or tissue Physical Proximity Sedentary Environment Wearing Protective Equipment | -- Occasionally 11-33% Occasionally 11-33% Occasionally 11-33% Occasionally 11-33% |
PHYSICAL DEMANDS
| | Frequency | Weight |
| Keyboarding Lifting Pushing/Pulling Reaching Sitting Standing Walking | Frequent 34-66% Occasionally 11-33% Occasionally 11-33% Occasionally 11-33% Frequent 34-66% Frequent 34-66% Frequent 34-66% | -- 10-20 lbs 10-20 lbs -- -- -- -- |
Required Education:
High school diploma or equivalent.
Preferred Education:
Bachelor's degree
Required Experience:
Four years of related experience. With preferred degree, no experience required.
Preferred Experience:
Oncology treatment trials data entry such as adverse events, SAE's (serious adverse events) and treatment, research data management, current or past experience being in a Research Data Coordinator role, biospecimen coordination (handling/processing/storing/shipping), monitoring visit coordination with CROs or IND office, experience with Epic.
Work Schedule:
4 days a week onsite during orientation and 3 days a week thereafter.
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: 171987
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 41,500
- Midpoint Salary: US Dollar (USD) 52,000
- Maximum Salary : US Dollar (USD) 62,500
- FLSA: non-exempt and 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
#LI-Hybrid
