Job Description

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

SUMMARY

The primary purpose of the Research Data Coordinator position is to assist in the daily activities of minimal risk and complex pediatric clinical research through collaboration with multiple investigators, research nurses, patients, pharmacists, pathologists, radiologists, surgeons and other allied health care personnel for information exchange regarding clinical trials.

JOB SPECIFIC COMPETENCIES

Regulatory Submission & Maintenance of Essential Documents Submits initial and ongoing regulatory information for a wide-range of pediatric protocols via institutional systems and processes to appropriate departments and committees so that protocols may be reviewed, approved and activated and remain in compliance throughout the study. In collaboration with principal investigators, research nurses, and other data coordinators, develops and maintains a processing and tracking system for all protocol related paperwork; develops regulatory binders; uses PDOL protocol tracking system; and maintains organized case report forms and source documents for all assigned protocols. Ensures that all sponsor and institutional required essential documents are obtained and maintained for each study including the delegation of authority log, 1572, CVs, licenses, and all training documentation. Assists with audit preparation and with the review and submission of serious adverse events and violations. Participates in the maintenance of the deviation log and ensures it is submitted annually with the continuing review.

Protocol Data and Source Documents Maintenance Performs protocol specific tasks such as:

a. Uses the CORe system and the patient's electronic medical record to review patient eligibility of potential study cases, to track active and follow-up patients, for data entry purposes, and to pull protocol specific information for patient shadow charts.

b. Documents enrollment of patients on clinical trials in sponsor

and institutional systems as required. Assists in obtaining consents in minimal risk studies.

c. Processes/ships routine blood samples; serves as an

information source for PIs, research nurses and sponsors

regarding status of samples collected from patients.

d. Enters study data (case report forms, adverse events, etc.)

into sponsor, institutional and FDA systems as required.

e. Tracks protocol related labs and research tests and the test

outcomes; coordinates with relevant testing centers and

sponsor.

f. Develops a study binder and data road map for each assigned study to include protocol specific data personnel requirements and instructions, for use as a reference throughout the study and for back-up purposes.

g. Addresses data entry queries on a regular basis according to the protocol requirements, Performs protocol specific tasks such as:

a. Uses the CORe system and the patient's electronic medical record to review patient eligibility of potential study cases, to track active and follow-up patients, for data entry purposes, and to pull protocol specific information for patient shadow charts.

b. Documents enrollment of patients on clinical trials in sponsor

and institutional systems as required. Assists in obtaining consents in minimal risk studies.

c. Processes/ships routine blood samples; serves as an

information source for PIs, research nurses and sponsors

regarding status of samples collected from patients.

d. Enters study data (case report forms, adverse events, etc.)

into sponsor, institutional and FDA systems as required.

e. Tracks protocol related labs and research tests and the test

outcomes; coordinates with relevant testing centers and

sponsor.

f. Develops a study binder and data road map for each assigned study to include protocol specific data personnel requirements and instructions, for use as a reference throughout the study and for back-up purposes.

g. Addresses data entry queries on a regular basis according to the protocol requirements, checks in each active study's database for any pending queries, and provides query updates to the study team.

Study Liaison

Acts as liaison for the principle investigators in order to maintain appropriate relationships with study monitors, sponsors, and the IRB. Attends disease team & COG meetings to provide and receive updates for assigned studies to ensure that all study team members know the status of the studies. Coordinates and facilitates site initiation, monitoring, close out and auditing site visits to ensure that all study team members, the monitors/auditors, and the sponsor are able to provide and receive all information needed and have all needed resources for the visit.

Education

Required: High school diploma or equivalent.

Preferred degree: Bachelor's degree

Experience

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

Preferred Experience: knowledge of Stem Cell Transplant and previous clinical data entry and medical terminology. Research and Microsoft Excel experience needed.

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: 137213
* Employment Status: Full-Time
* Employee Status: Regular
* FLSA: non-exempt, eligible for overtime, and is subject to the provisions of the Fair Labor Standards Act (FLSA)
* Work Week: Day/Evening
* Fund Type: Soft
* Pivotal Position: No
* Minimum Salary: US Dollar (USD) 33,200
* Midpoint Salary: US Dollar (USD) 41,500
* Maximum Salary : US Dollar (USD) 49,800
* Science Jobs: Yes