Clinical Research Scientist - Investigational Cancer Therapeutics

The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report's 2024-2025 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the Clinical Research Scientist position is to plan, coordinate, design, supervise, and implement clinical trials and clinical research projects. Apply scientific/medical expertise and experience to plan, coordinate, and supervise the evaluation of clinical trials and translational research data. Ensure the quality of resulting publications. The Clinical Research Scientist will support and collaborate with the Precision Oncology Decision Support (PODS) team to lead team-wide efforts that enhance the quality, quantity, and/or efficiency for delivering patient-specific reports to MD Anderson and collaborating oncologists that provide an interpretation of patients' molecular testing results with available therapeutic options for actionable alterations. The CRS will serve as a subject matter expert in decision support to a variety of audiences upon request. He/she will also contribute to the design and creation of manuscripts reflecting PODS and a variety knowledge related to personalized cancer therapy.

KEY FUNCTIONS

1. Clinical and translational research projects and initiatives.

· Assist principal investigator in the development and design of clinical and translational research to ensure value and feasibility of proposal.

· Assist principal investigator in determining the specific goals or objectives to be attained.

· Develop and maintain standard procedures and protocols to ensure the quality and integrity of research data to be obtained.

· Identify and implement strategies to enhance collaboration between investigators and clinical or research scientists.

· Abstract medical and scientific information and provide lay language versions when required.

2. Clinical and translational data analysis.

· Review protocol documents including abstracts, text, and informed consent for relevant information.

· Review medical records to extract data points.

· Review and evaluate clinical protocol and translational research data, including laboratory correlates data.

· Ensure that the relevant clinical data is collected at designated stages in the treatment process.

· Provide sound data analysis and interpretation of results for manuscripts and grant research plans.

· Prepare data and information related to protocols, grants, abstracts, and manuscript submissions, as needed.

3. Reporting, writing, and editing projects.

· Compose technical reports, abstracts, slide presentations, spreadsheets, posters, and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.

- Copyedit technical reports.

- Proofread galley proofs of manuscripts nearing publication.

- Utilize technical writing ability to compose and abstract medical and scientific information for

preparation of written correspondence, reports, and protocols under the direction of study investigator.

- Compile, write, and submit project results to principal investigator.

· Generate PODS annotation reports for MDA patients or MDA collaborators.

· Edit and/or write sections of protocols and reports as directed by study investigator.

· Prepare specific protocol reports and analysis to aid decisions regarding therapeutic efficacy.

· Prepare documents for publication by reviewing analyses and interpretations of data to ensure accuracy and alignment with research data. Ensure clarity of expression.

· Prepare abstracts of professional literature of a technical nature based on reading and comprehension of the material.

· Ensure that the data collected reflects the requested information and can be provided in accordance with specified guidelines.

· Compile information and draft presentations to provide the most effective arrangement of data (financial, scientific, medical, business, and academic).

· Produce medical illustrations, publication graphics, scientific posters, and slide presentations for national and international meetings.

· Present findings of research projects to professional groups

4. Coordination of activities related to initiation and conduct of clinical trials.

· Work with staff in Patient Business Services to develop research charge tickets for protocols.

· Interact with clinic staff to make sure research charge tickets are used appropriately and that billing to sponsored study accounts is accurate.

· Timely notification of patient on study to patient access coordinator and PBS.

· Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings. Identify and meet the educational, emotional, and psychosocial needs of patient and their families while on phase I clinical trials.

· Coordinate, evaluate, and follow the patient's participation in clinical settings. Collaborate with the multidisciplinary team as necessary to document patient care, achieve objectives of phase I trials, and maintain patient safety.

· Instruct co-workers in allied fields in procedures for recording patient information.

· Maintain data necessary for audits.

· 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.

5. Coordination of regulatory correspondence on clinical research studies.

· Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).

· Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting 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.

6. Direct support to clinical trial research protocols.

· Review protocol documents including abstracts, text and informed consent for relevant information.

· Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in PDMS per protocol. Communicate necessary registration information to sponsoring drug company as directed by PI, and with the assistance of the research nurse.

· Schedule patient tests; keep patients informed about test results and studies.

· Assist in obtaining consent for studies.

· Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.

· Complete case report forms in a timely and accurate fashion.

· Assist in the screening for adverse events.

· Assist in modifying consents; submit to IRB.

· Follow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control.

· Provide support for labor-intensive protocols as needed.

· Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients.

· Act as a lead in data collection by retrieving protocol information via computer and visual chart review and by communicating directly with outlying healthcare providers to schedule and procure testing and treatment records.

· Obtain outside films, surgical, pathology and lab reports as needed per protocol and submitting specimens/films for reading.

· 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.

7. Assist the primary investigator in collection and evaluation of data.

· Retrieve protocol-related data as documented in the medical record and accurately enter it into a computerized database or on a handwritten case report form.

· Generate CORE data reports, protocol summary reports, and user-generated data reports as requested.

· Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.

· 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.

· Additional projects, as assigned.

8. Collect or facilitate the collection of specimens as outlined in assigned protocols upon request.

· Process samples, labels, pipettes, and transfer to appropriate containers ultimately storing specimens at specified temperatures.

· Develop and maintain database for tracking specimens with high level of accuracy.

· Serve as an information source regarding status of samples collected from patients on given protocols for PI and sponsors.

· 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.

9. Other assigned duties.

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 ability to deal effectively with a variety of individuals and situations is essential, as is the ability to meet conflicting deadlines and to work in stressful conditions due to deadline requirements. 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/program and take the initiative in making decisions and taking actions to further these goals.

The above functions require the following abilities and skills:

· Highly developed analytical and conceptual skills paired with detail orientation, exceptional interpersonal skills, and a demonstrated ability to creatively and innovatively approach problem solving.

· Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and effective interactions with patients and co-workers.

· 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.

· Requires use of computer via keyboard, and operating 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.)

· Ability to 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: Ph.D. or Medical degree.

EXPERIENCE

None.

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: 173030
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 66,500
• Midpoint Salary: US Dollar (USD) 83,000
• Maximum Salary : US Dollar (USD) 99,500
• FLSA: exempt and not eligible for overtime pay
• Fund Type: Soft
• Work Location: Hybrid Onsite/Remote
• Pivotal Position: Yes
• Referral Bonus Available?: No
• Relocation Assistance Available?: Yes
• Science Jobs: Yes

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