Coordinator Clinical Studies - 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.

Bringing the most exciting new agents for cancer treatment more quickly from the laboratory to clinical trials is the goal of MD Anderson's Phase I Clinical Trials Program in the Department of Investigational Cancer Therapeutics. The program is a centralized resource for physician-scientists throughout the institution and community physicians looking for clinical trials for their patients with advanced cancer. The Phase I Clinical Trials Program is leading multi-disciplinary, first-in-man studies that include multiple tumor types in a single study.

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.

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.

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.

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 Master's degree, one year of required experience.

Preferred: Human Research Subjects 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