- Develops and maintains a process and tracking system for all protocol related paperwork.
- Communicates verbally and in writing, as needed with internal reviewers or external agencies.
- Coordinates, evaluates and follows patient progress while on studies maintaining knowledge of adverse events, protocol related labs and research tests, protocol responses.
- Collaborates with physicians, mid level practitioners, research nurses, and data managers to assure appropriate documentation of patient care and obtain the necessary information required by the protocol.
- Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient setting. Identify and meet the educational, emotional and psychosocial needs of patient and their families while on clinical trials.
- Coordinate, evaluate, and follow the patient's participation in clinical settings.
- Performs protocol specific duties under direct supervision of protocol PI, research nurses manager/supervisor.
- Obtains consent for research studies
- Assist in screening for adverse events (AEs) and tracks participants for development of these AEs
- Schedule patient tests; keep participants and all involved study team members informed about these test results and studies
- Monitor protocol compliance by assisting in coordination of protocol specific lab, radiographic, and clinical evaluation of patients
- Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in Oncore (or other system) per protocol.
- Complete case report forms in a timely and accurate fashion.
- Develop and maintain databases for collection of research studies
- Assist in the preparation of scheduled status reports
- Generate data reports, protocol summary reports and user generated data reports as requested
- Prepare reports for the PI/study team for regular update meetings
- Collect or facilitate the collection of specimens as outlined in assigned protocols upon request.
- Process samples
- 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 Human Subject Research Manual.
- Attend research meetings and conferences.
- Attend approved off site meetings and conferences.
- Supplement education as needed through use of reference materials, lectures, etc.
- Be punctual in arriving at all professional functions.
- Inform appropriate staff and arrange coverage for necessary functions when absent
- Other duties as assigned.
- Requisition ID: 166270
- Employment Status:
- Employee Status:
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- Minimum Salary:
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Coord, Clinical Studies - Houston, United States - MD Anderson Cancer Center
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Description
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.
JOB SPECIFIC COMPETENCIES
Coordination clinical and translational research protocols
Coordination of data entry
Coordination of biospecimen collections
Maintain a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences
EDUCATION:
Bachelor's degree.
EXPERIENCE:
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.
FLSA:
non-exempt and eligible for overtime pay
Fund Type:
Soft
Work Location:
Hybrid Onsite/Remote
Pivotal Position:
No
Referral Bonus Available?:
No
Relocation Assistance Available?:
No
Science Jobs:
No
\#LI-Hybrid