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Research Data Management Maintains knowledge of protocol specific guidelines and general procedures for data management practices for research 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 Abstracts and collects patient data from electronic health record and other relevant source Enters research study data into electronic case report forms (CRFs) or local data systems as required, in accordance with protocol requirements and departmental Monitors and records in relevant systems outside laboratory data for protocol patients and ensures PI and research nurse are notified in a timely Performs ongoing and concurrent review of data to ensure completeness and Addresses data entry omissions or inconsistencies and amends errors in a timely Communicates research data revision requests to the physician and/or clinical research staff for Trains other members of research staff on database utilization and 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 Maintains telephone contact with other institutions participating in studies and collects data as
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 Reviews new protocols for data management Assists in development of laboratory manual and specimen handling, processing, and storage pathways as Participates in Site Initiation Visits (SIVs), conference calls and protocol Schedules and performs start-up meetings with multi-center research staff and/or participating sites on specific data or biospecimen-related roles and Schedules internal and external auditor/monitor visits for Assists with annual reviews, updates, and response data, and generates reports as Assists with data compilation for the preparation of information and reports for manuscript/grant Collaborates with physician, study team, and departmental protocol administration team to complete financial and regulatory tasks as Contributes to milestone logs of patient activity to assist in hospital account reconciliation and to facilitate compensation from sponsors of clinical trials as
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 Conducts structured interviews with research subjects for protocol data Assists with follow-up appointments and provides telephone reminders to 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 Screens medical record to identify potential study subjects and collaborates with research nurse team member and or study PI regarding subject eligibility Develops and maintains a detailing screening log as well as patient tracking Participates in the informed consent process for minimal-risk studies and registers subjects utilizing the Clinical Oncology Research (CORe) system according to institutional policy as Documents study specific information appropriately in the patient medical
Assists in retrieval of pathology slides/blocks and mail as specified in Assists in transportation of blood/tissue specimens between the labs, and clinic as needed by Collects, processes, stores, and ships blood, tissue, and other body fluid specimens according to institutional and protocol specific
Other Duties Interacts with members of interdisciplinary team inter and intra-departmentally to obtain pertinent information and verify the status of ongoing Verbal, telephone, email and written communications are timely and intent is clearly communicated with institutional and other
Required Education:
High school diploma or
Preferred Education:
Bachelor's
Required Experience:
Four years of related With preferred degree, no experience
Preferred Experience/Skills:
Experience data entry for clinical trials, Excel experience, database experience with RAVE, Prometheus,
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
Additional Information
Requisition ID: 151850
Employment Status: Full-Time
Employee Status: Regular
Work Week: Days
Minimum Salary: US Dollar (USD) 39,500
Midpoint Salary: US Dollar (USD) 49,500
Maximum Salary : US Dollar (USD) 59,500
FLSA: non-exempt and eligible for overtime pay
Fund Type: Soft
Work Location: Hybrid Onsite/Remote
Pivotal Position: No
Science Jobs: No
Skills :
Full Time