Research Data Specialist - Investigational Cancer Therapeutics

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 Research Data Specialist position is collaboration with the research team and principal investigator in conduct of large-scale multi-protocol, multi-institutional, clinical trial projects. Assists with project oversight by assuring protocol compliance, data integrity, and communication of pertinent protocol information. Provides training and orientation of new research staff.

KEY FUNCTIONS

1.Specimen collection and processing

-Consent patients for research blood draws.

-Collect and store the patient samples for analysis in the laboratory.

-Accurately label all samples.

-Enter sample data into database in accordance with prescribed procedures.

-Process samples according to protocol requirements (e.g., centrifuge to obtain plasma or serum).

-Label, pipette, and transfer to appropriate containers and store at specified temperature.

2.Design, implement, monitor, and report on clinical research project status, ensuring on-time performance

•Perform accurate and timely capture of subject information in various research data system applications. Utilize knowledge of various disease states to determine the appropriate clinical information to report. Information reviewed may include, but is not limited to, treatment records, clinical evaluations, diagnostic test results, records of surgery, and pathology information.

•Develop and maintain systems for controlling the data flow for single-institution and/or multi-center projects. Systems may include a range of industry standard word processing applications and/or web accessible databases.

•Work closely with research nurse to ensure consistency between protocol database and source documentation. Perform source document verification of protocol compliance and drug accountability prior to research data capture. Generate written queries to external sources for missing/deficient source documentation, patient charts and other outside documents.

•Coordinate meetings with principal investigator and research team to review project status. Develop meeting agendas and provide relevant reports to support investigator's research oversight.

•Develop protocol-specific tools, such as data collection instruments (case report forms) and other study materials.

•Review new concepts and protocols in development. Communicate recommendations regarding protocol inconsistencies and requirements.

•Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the department training manual and presented at weekly training meetings.

3.Analysis, quality assurance, and reporting of clinical research information

•Coordinate routine monitoring and audits with industry sponsor pharmaceutical representatives or clinical research organizations. Provide sufficient, appropriate, and timely responses to sponsor verbal and written queries.

•Generate research reports from databases and/or collaborate with sponsor data support teams to acquire pertinent reports.

•In conjunction with the research nurse, conduct routine monitoring in accordance with departmental quality assurance SOPs for multicenter studies for which MDA is the lead institution.

•Participate in departmental clinical research quality assurance initiatives.

•Provide data and information related to protocols, grants, abstracts, and manuscript submissions, as needed. Assist in writing abstracts, manuscripts, grants, and correspondence.

4. Research education and training

•Train and/or orient data coordination staff to the department and to clinical research procedures/processes. Serve as a resource for research personnel regarding protocols and compliance information.

•Communicate with the PI, research nurse and others regarding upcoming deadlines, research and protocol meetings, and other pertinent information.

•Develop and provide educational presentations for the research training meetings.

•Implement changes to meet protocol goals.

5.Administrative research functions

•In consultation with the research nurse and PI, complete and submit Continuing Reviews, Investigational New Drug (IND) reports, sponsor and other required reports in a timely manner.

•Participate in protocol start up meetings and close-out visits.

•Coordinate and prepare a monthly update for protocol review.

•Participate in the development of policies, procedures, and work flow processes to ensure project efficiency and effectiveness.

6.Research-related activities

-Perform EKGs for protocol patients, as assigned.

-Attend clinical protocol start-up meetings with sponsor company representatives and institutional clinical personnel to assure that sample collection procedures and forms are fully understood.

-Package samples so that they arrive at destination in a suitable condition.

-Arrange shipment of sample boxes with a suitable air freight carrier and contact collaborators or sponsor personnel to coordinate shipments and verify receipt of samples.

-Handle dry ice.

7.Supply inventory and lab maintenance

-Maintain adequate stock of general and phlebotomy supplies.

-Know the procedure for obtaining repair or maintenance for lab equipment.

-Prepare stock solutions.

-Perform routine laboratory jobs (glassware washing, contact hazardous waste collection services, package medical waste in biohazard bags, etc.).

-Learn to operate laboratory equipment and apparatus and perform routine operator maintenance.

-Maintain alertness and careful attention to avoid injury to self and others due to chemicals and hazardous materials in the laboratory.

8.Other duties as assigned.

The performance for all expected outcomes is measured by observation by supervisor, reports from faculty and co-workers, the accuracy and timeliness of work produced, and the demonstrated ability to effectively work under stress. The position also requires one to anticipate needs, to recognize situations requiring assistance and have the ability to refer or perform any necessary tasks, and to comprehend the goals of the department and take the initiative in making decisions and taking actions to further these goals.

The above functions require the following abilities and skills:

•Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and ability to interact effectively with patients and co-workers.

•Strong attention to detail.

•Strong organizational skills.

•Ability to work with personal computers using standard word processing software, spreadsheets, and programs for database and graphics usage.

•Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds.

•Use of computer via keyboard, facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button, multiple line telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)

•Be clearly understood by verbal communication in face-to-face encounters and by telephone.

•Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing.

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: Bachelor's degree in a related field.

EXPERIENCE

Required: Two years research study experience. May substitute required education degree with additional years or equivalent experience or completed years of college on a one to one basis.

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