Research Data Coordinator Endocrine Neoplasia and HD

Houston, Texas
May 26 2021
Organization Type
Provide administrative & patient care services for the coordination of research studies. Coordinate & gather patient data for research studies. Maintain patient database for research studies.

1. Data Entry, Analysis, & Reporting"

* Develop & maintain databases for collection of research data
* Transfer patient information into electronic database & case books; act as lead for ensuring maintenance of accurate data entry.
* Retrieve protocol information via computer & visual chart reviews & by communicating directly with both internal & external healthcare providers to schedule & procure testing & treatment records. Obtain outside films, surgical, pathology, & lab reports as needed.
* Review medical records to extract data points.
* Perform data entry into database & casebooks & statistical analysis programs
* Collect & enter data into case report forms (CRFs) & in PDMS/SPONSOR DATABASE
* Assist with data analysis and reconciliation of protocol expenses and/or patient care charges
* Make survival calls & appropriately record data.
* Maintain accurate & up-to-date patient flow sheet, to include entry of toxicities, adverse events, follow-up visits, dose modifications, & any other protocol-required data.
* Generate PDMS/SPONSOR DATABASE data reports, protocol summary reports, & user-generated data reports, as requested.
* Provide support for data & information related to protocols, grants, abstracts, & manuscript submissions, as needed. Assist in writing abstracts, manuscripts, grants, & correspondence.
* Maintain schedules for timely submission of data.

2. Patient Care Services and Regulatory Coordination:

* Assist research nurses & other clinical research personnel with patient-related activities; to ensure compliance with protocol schedule of assessments. Participate in coordination of regulatory correspondence & protocol administration on departmental clinical research, as needed.
* Maintain Endocrine Clinical Research Calendar, to include patient appointments, research meetings, monitor visits, research staff/faculty time off.
* Coordinate preparation of visit schedules for milestone invoicing & patient travel reimbursement
* Process accurate & timely research billing activities; assist in authorization of managed care patients. Coordinate with Sr Admin Assistant for electronic filing on shared Research Drive & mailing to PBS.
* Schedule patient visits per protocol, ensuring timelines are met.
* Interpret & coordinate physicians' orders to schedule diagnostic tests, procedures, treatments, & physician appointments.
* Collaborate with staff of PIs to maintain physician templates to ensure patients appointments within protocol timelines.
* Coordinate with nurses for patient appointment communication, including information regarding schedule, preparations for appointments, and available services
* Maintain adequate stock of general and phlebotomy supplies
* Responsible for security & confidentiality of patient information at all times.
* Screen phone calls professionally; triage patient calls to research nursing.
* Relay immediately important patient messages to research nurses.
* Coordinate site qualification visits by pharmaceutical companies
* Coordinate Monitoring visits from sponsors
* Prepare, submit, & maintain filing system for External Serious Adverse Event reports to the IRB.
* Communicate with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical &/or governmental sponsors, e.g., NCI).
* Prepare reports for sponsoring agencies, as specified by reporting requirements
* Maintain information on shared Endo Research Drive, to include scanned copies & files of regulatory documents, CV's, medical licenses, protocols, protocol amendments, IBs, research billing tickets (blank form & all completed)

3. Primary Study Coordination for Minimal Risk Studies:

* Serve as primary study coordinator on minimal risk studies, and/or for clinical protocols that are primarily patient survey and data
* Identify patients eligible for study enrollment; create a tracking system/log to ensure enrollment of eligible patients.
* Enter all enrolled patients into CORe system.
* Administer informed consent to patients in the Endocrine clinic, as delegated by the PI, on minimal risk studies.
* Coordinate biospecimen and/or blood specimen collection and/or administer questionnaires as per protocol.

4. Education and Marginal Functions:

* Maintain a high level of professional expertise & credibility through educational programs, including on-site training & off-site conferences. Perform marginal duties as assigned.
* Attend Investigator meetings as assigned.
* Assist in the coordination & preparation of a monthly update for protocol review.
* Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.
* Attend department research meetings & conferences.
* Attend approved off-site meetings & conferences.
* Supplement education as needed through use of reference materials, lectures, etc.
* Other duties as assigned.

Required: High school diploma or equivalent.

Preferred degree: Bachelor's degree.

Required: Two years of related experience. With preferred degree, no experience required.

Preferred: Experience working and updating databases.

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.