Job Description

The mission of The University of Texas MD 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 Clinical Studies Coordinator is to provide administrative and patient care services for the coordination of clinical trials.

Key Functions

Coordination/support to clinical trials and research protocols
1. Ensures that the implementation of assigned studies is in accordance with Good Clinical Practice, Federal regulations and institutional policies. Under the supervision of medical staff, assists the investigator in the overall conduct of assigned clinical trials through the following activities:
participates in departmental protocol review
assists with protocol and consent revisions as needed,
assists with the submission process as needed,
Actively participates in protocol meetings, such as investigator and initiation meetings
manages protocols at appropriate intervals and participates in monitoring and a udit activities.
Appropriately submits information regarding adverse events to the IRB
coordinates, evaluates, and documents patient participation in clinical trials.
Effectively follows patients on protocol by maintaining knowledge of their adverse events and response to treatment.
Appropriately documents findings in the medical record in collaboration with physicians, mid-level providers, research nurses, and data managers.

2. Performs protocol-specific duties under the supervision of the protocol Physician Investigator to meet the protocol requirements and compliance including, but not limited to:
Screening and determination of eligibility of potential new patients
assisting in the informed consent process
schedules, tracks, and performs protocol-specific tests and procedures
performs data entry for assigned research studies focusing on continuous patient follow-up
assist the investigator in data file preparation
participates in data review meetings as required by the department

3. Prepares specific protocol reports and analysis to aid decisions regard i ng therapeutic efficacy and to assist in manuscript preparation and grant submissions.

4. Duties may also include phlebotomy and processing of specimens. Coordinates the acquisition of research blood and tissue samples. Visually monitors, manages, and orders the consumable lab supplies necessary to meet protocol requirements for research specimens. Maintains and manages documentation of research specimens and research supplies. Assists in the maintenance of Joint Commission standards for lab supplies.

5. Assists with the development and submission of research milestone logs in a timely manner and in accordance with the departmental and institutional policies. Ensures that research related questions are answered as requested by the departmental financial staff for reconciliation of sponsored study accounts.

6. Provides guidance and instruction to research support staff as needed to promote protocol compliance in accordance with federal and institutional standards. Communicates with clinical staff to ensure protocol patient safety.
Example:
i. Participates as needed in the orientation of new staff members
ii. Assists the project leads with the writing and presentation of technical reports and presentation materials.
iii. Initiates Self Audits

7. Collaboration/Clinical Trial Management:
Timely management of Tumor Measurement assessment, QIAC ordering, off site meetings with radiology collaborator.
Participation in ongoing toxicity meetings with PI's, discussion of all SAE's and concerning AE's. Participates in weekly education meetings, bi-weekly staff meetings, regulatory meetings, and any educational opportunity meeting when available.
SAE reporting completed within sponsor and MDACC guidelines
Clinical Content Template (CCT) creation for new protocols and amendments per department policy including collaboration with pharmacy.
Provide clinical coverage for other colleagues and follow the process for time off including providing adequate written and oral coverage reports

Other Other duties as assigned.

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 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: 137924
* 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) 50,800
* Midpoint Salary: US Dollar (USD) 63,500
* Maximum Salary : US Dollar (USD) 76,200
* Science Jobs: Yes