Coordinator, Clinical Studies - 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 2022-2023 rankings. It is one of the nation's original three comprehensive cancer centers designated by the National Cancer Institute.

The primary purpose of the Coordinator, Clinical Studies is to provide clinical evaluation, coordination, implementation, and monitoring of patients enrolled in phase I research protocols. Also serves as an effective point of contact regarding status and progress of phase I trials. Impacts clinical trials patients in designated protocols. Utilizes medical or clinical knowledge for supervised non-clinical patient interaction for the purposes of research data gathering and monitoring. Requires strict adherence to the policies and procedures of the institution.

KEY FUNCTIONS

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. Other duties as assigned.

The performance for all expected outcomes is measured by observation by supervisor, reports from physicians 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 program and take the initiative in making decisions and taking actions to further these goals.

The above functions require the following abilities and skills:

· Read, interpret, and process large quantities of printed information.

· Ability to be clearly understood by verbal communication in face-to-face encounters and by telephone, read printed and written data, assimilate pertinent information in order to compose written correspondence.

· A strong command of the English language and be able to communicate well verbally and in writing. Must be able to understand verbal and written directions.

· Engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis. Respond and assist other employees and visitors, as required.

· Ability to organize focus on task is essential.

· Compare database and file material on an ongoing basis.

· Build and/or maintain simple Excel spreadsheets. Manually record data, by use of a computer and keyboard.

· Travel to and from different destinations, including inpatient and outpatient care areas.

· Maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, lifting, 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		No		X	Yes
Exposure to harmful chemicals		No		X	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.

Preferred: Master's degree in a related field.

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: 171540
• Employment Status: Full-Time
• Employee Status: Regular
• Work Week: Days
• Minimum Salary: US Dollar (USD) 55,500
• Midpoint Salary: US Dollar (USD) 69,500
• Maximum Salary : US Dollar (USD) 83,500
• FLSA: non-exempt and 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: No

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