MD Anderson Cancer Center Coordinator, Clinical Studies in Houston, Texas
The primary purpose of the Clinical Studies Coordinator is to provide all study related coordination, including but not limited to data management, patient coordination, and regulatory management for clinical research studies. This person will work directly with the principle investigators, medical staff, research staff, and pharmaceutical sponsors and monitors.
Screen patient for protocol eligibility to include screening protocols.
Request insurance clearance prior to consenting patient.
Identify patient and coordinate scheduling follow-up appointment, labs, CT scan/MRI and other tests/procedures with data coordinators and/or PSCs at the GI Center.
Assist in obtaining informed consent document.
Pre-enroll in CORe per protocol.
Follow-up on screening tests/procedure for eligibility per protocol.
Obtain baseline data by interviewing patient/family and/or reviewing records.
Register and/or assign treatment in CORe.
Complete documentation - informed consent note, eligibility note and on-study note.
Complete and submit research charges.
Send appointment request to CTRC and/or ATC per protocol.
Request outside records, tissue block/slides per protocol and maintain records.
Coordinate protocol follow-up, labs, tests/procedures per protocol.
Interview patient and collect data - pill diary, toxicity, con-med and/or questionnaires.
Assist in assessing adverse events per CTCAE.
Assist in gathering measurements per protocol.
Assist in re-consenting patient as necessary.
Assist preparing SAE report.
Complete protocol deviation form as necessary.
Assist completing violation form and send to the Regulatory team for IRB submission.
Prepare for routine monitoring and/or audits.
Order correlative samples per protocol and maintain records/database.
Complete Protocol Summary in CORe.
Follow patient for survival per protocol and document.
Assist preparing IRB Annual Continuing review, IND Annual Report, ePAAC, DSMB report per protocol.
Cover co-workers' patients as needed.
Assist the primary investigator in collection and evaluation of data.
Maintain screening/enrollment log.
Maintain informed consent binder.
Generate patient enrollment reports per request.
To maintain a high level of professional expertise and credibility through educational programs, including on-site training and off-site conferences.
Attend department research meetings and conferences.
Supplement education as needed through use of reference materials, lectures.
Adhere to all departmental and institutional policies and procedures.
Acts as preceptor/mentor for new staff.
Commitment to the well-being of each other, support a healthy work environment, diversity and exclusivity, and team work.
Commitment to our Core Values and Code of Conduct.
Respect each other and demonstrate sincere appreciation.
Practice forgiveness. Mistakes happen, learn from it and move on.
Hold each other accountable.
Bachelor's degree. 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
Requisition ID: 138227
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: No