Job Description

Coordinator, Clinical Studies

SUMMARY

The primary purpose of the Coordinator of Clinical Studies position is to assist with the coordination of all aspects related to departmental research studies.

JOB SPECIFIC COMPETENCIES
Protocol Research
Provides all study-related coordination through the lifetime of a protocol, including development, review process, implementation and closeout.

Communicates with researchers, research staff, sponsors, the Office of Human Subject Protection, institutional review boards, regulatory agencies, and others, and maintains required documents, as needed and assigned.

Develops (or assists in development as needed) and maintains systems (databases and other) for tracking and processing all protocol-related data and documents during screening, accrual, as well as other research milestones. Prepares research folders for patients enrolled, assuring organization and timely addition of source documents as needed. Informs research staff and/or investigators of missing or inconsistent research data; ensures that all research data is accurate, updated, and consistent with protocol and institutional policies.
Clinical Study Management
Ensures effective identification and recruitment of patients through regular screening.

Obtains consents and creates on/off study notes for minimal-risk protocols (e.g. PA or LAB studies) as assigned.

Registers protocol patients into and maintains patient status in CORe or electronic case report form per departmental Standard Operating Procedures (SOPs) and per institutional standard practice.
Data Management
Coordinates the collection and evaluation of data collected from all research endeavors as assessed during patient hospital visits or stays, by mail, email, virtual methods, or documented in the medical record. Oversees accurate data entry into a computerized database or on a handwritten case report form. Utilizes computerized data management packages as necessary. Contacts outside physicians caring for protocol patients and obtains and conveys necessary information relating to the protocol. Enters patient data into REDCap or other programs as required. Updates worksheets and protocol flow sheets with patient data.

Quality Assurance
Performs periodic quality checks on the departmental/study databases following specific directions. This includes verification of information noted on the data collection forms and recorded in the computer database(s) or in data reports/extractions for internal and external consistency. Performs audits on protocol data/documents, ensuring that the implementation procedures are in compliance with the approved protocol and the regulatory requirements. That includes, but is not limited to, ensuring that eligibility criteria are met; evaluations required by protocol are performed within the approved timeline, and that patient registration and adverse event reporting procedures are followed. Prepares reports from the data collected. This includes reports from departmental, Brain and Spine Center and other institutional databases for various administrative/operational, clinical, and research purposes. Extracts patient data from these databases as needed for specific purposes following approved policies and procedures. Reports treatment responses, toxicities and adverse treatment reactions to protocol/research sponsors and the IRB by providing regular written or computerized reports as required. Provides protocol summary reports as needed.

Assists in preparation for monitoring visits, research audits, inspections and other quality assurance/compliance activities.
Other duties as assigned

Education Required: Bachelor's degree.

Experience Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.

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: 137411
* 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: Days
* Fund Type: Soft
* Pivotal Position: No
* Minimum Salary: US Dollar (USD) 50,800
* Midpoint Salary: US Dollar (USD) 63,500
* Maximum Salary : US Dollar (USD) 76,200
* Science Jobs: No