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.

The primary purpose of the Senior Coordinator, Research Data position is to provide administrative and patient care services for the coordination of research studies. Coordinates and gathers patient data for research studies. Maintains patient database in PDMS. Participates in research activities including registration, data collection, data analysis and the development of abstracts, manuscripts, and grants as designated by the principal investigator. Assists in the review of records before submission to pharmaceutical companies, federal agencies, internal groups, and other institutions.

Key Functions

1. To act in lead role for coordination of regulatory correspondence/protocol administration for departmental clinical research.
* Communicate verbally and in writing, as needed or as requested by study investigator, with internal reviewers (e.g., Surveillance Committee) or external agencies (e.g., pharmaceutical sponsors and/or governmental study sponsors, such as National Cancer Institute or Food and Drug Administration).
* Complete forms and comply with institutional, state, and/or federal regulations for study initiation, conduct, and termination.
* Assist in coordinating and send outgoing material and correspondence to institutional, state, and/or federal agencies.
* Prepare reports for the sponsoring agency, as specified by reporting requirements (e.g., monthly, semiannually, and annually for NCI studies).
* Inform sponsors and collaborators of regulatory status of protocols at least monthly in formal departmental protocol review meetings.
* Collect specimens as outlined in assigned protocols.
* Maintain a system for controlling paper flow for protocols and related grants, to include setting up and maintaining reference file system.
* Maintain and update protocol reference materials.
* Assist in the preparation of scheduled status reports describing interim data, using CORE.

2. To assist research nurses and other clinical research personnel with patient-related activities.
* * Obtain outside films, surgical pathology, and lab reports as required by protocol.
* Submit specimens/films for reading.
* Order protocol laboratory supplies, including tubes, air bills, and shipping supplies.
* Maintain adequate supply of protocol-related treatment forms.
* Assist with retrieval and return of medical charts, reports, and radiology films within the institution.
* Pick up special blood or tissue specimens correctly and in a timely fashion and transport to appropriate locations, as specified by protocols..
* Prepare tissue specimens correctly, as specified by protocols.
* Follow up on lab/translational data collection, processing, and compilation.
* Perform research ECGs in accordance with specified protocol instructions.
1. Data entry, analysis, and reporting.
* Develop and maintain databases for collection of research data.
* Transfer patient information into the electronic database and case books and act as lead for ensuring maintenance of accurate data entry.
* Retrieve protocol information via computer and visual chart reviews and by communicating directly with both internal and external healthcare providers to schedule and procure testing and treatment records. Obtain outside films, surgical, pathology, and lab reports as needed. Submit specimens/films for reading.
* Review medical records to extract data points.
* Perform data entry into database and casebooks and statistical analysis programs.
* Collect and enter data into case report forms (CRFs) and in PDMS.
* Assist with data analysis.
* Make survival calls and appropriately record the data.
* Maintain accurate and up-to-date patient flowsheet, to include entry of toxicities, adverse events, follow-up visits, dose modifications, and any other protocol-required data.
* Generate PDMS data reports, protocol summary reports, and user-generated data reports, as requested.
* Provide support for data and information related to protocols, grants, abstracts, and manuscript submissions, as needed. Assist in writing abstracts, manuscripts, grants, and correspondence.
* Maintain schedules for timely submission of grant data.

4. Professional expertise and credibility through educational programs/training and mentoring of new staff.
* Attend department research meetings and conferences.
* Attend approved off-site meetings and conferences.
* Supplement education as needed through use of reference materials, lectures, etc.
* Be punctual in arriving at all professional functions.
* Inform appropriate staff and arrange coverage for necessary functions when absent.
* Assist in the training and mentoring of new clinical trials staff in regard to department policies and procedures for the conduct of clinical trials and the appropriate completion of data entry.

5. Organizational system for research meetings, deadlines.
* Generate documents on computer, using word processing, spreadsheet, and other software to produce professional appearance.
* Assist in the coordination and preparation of a monthly update for protocol review.
* Communicate with appropriate individual(s) regarding upcoming deadlines, meetings, etc.

Working Conditions

This position requires:

Working in Office Environment

No

X

Yes

Working in Patient Care Unit (e.g. Nursing unit; outpatient clinic)

No

X

Yes

Exposure to human/animal blood, body fluids, or tissues

X

No

Yes

Exposure to harmful chemicals

X

No

Yes

Exposure to radiation

X

No

Yes

Exposure to animals

X

No

Yes

Physical Demands

Indicate the time required to do each of the following physical demands:

Time Spent

Never

0%

Occasionally

1-33%

Frequently

34-66%

Continuously

67-100%

Standing

X

Walking

X

Sitting

X

Reaching

X

Lifting/Carrying

Up to 10 lbs

X

10lbs to 50 lbs

X

More than 50 lbs

X

Pushing/Pulling

Up to 10 lbs

X

10lbs to 50 lbs

X

More than 50 lbs

X

Use computer/keyboard

X

Education

Required: High school diploma or equivalent.

Preferred Education: Bachelor's degree

Experience

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

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: 138414
* 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) 38,000
* Midpoint Salary: US Dollar (USD) 47,500
* Maximum Salary : US Dollar (USD) 57,000
* Science Jobs: No