MD Anderson Center
Coordinator, Research Data - Investigational Cancer Therapeutics
MD Anderson Center, Houston, Texas, United States, 77246
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, Research Data is to provide administrative and patient care services for the coordination of clinical research studies.
KEY FUNCTIONS
Data Management (35%)
• Perform data entry and transfer of patient information into electronic databases.
• Review medical records to extract data points.
• Collect, store and maintain accurate and up-to-date source documentation to support data entry.
• Meet contractual agreements for data entry and query resolution timelines; meet external deadlines to support protocol milestones.
• Develop and maintain systems; protocol-specific tools, such as case report forms; and other study materials to control the data flow for single-institution and/or multi-center projects.
• Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the institutional policies and department training.
Clinical Research Support (30%)
• Reconcile electronic medical records and source documentation to facilitate accurate patient data reporting consistent with institutional, industry and government standards.
• Prepare clinical trial documents for regulatory compliance.
• Coordinate and prepare weekly updates for protocol review.
• Meet with the Principal Investigator and study team routinely to review study status.
• Alert appropriate individuals regarding upcoming deadlines, meetings, audits, etc.
• Communicate verbally and in-writing with internal and external collaborators to meet study objectives.
Host External Research Personnel (25%)
• Facilitate external research personnel vetting process to comply with institutional and HIPAA requirements.
• Coordinate routine monitoring visits with internal and industry representatives.
• Collaborate with external departments for source document verification.
• Act as a lead contact for protocol data to answer questions and problem solve.
• Support deadlines, routine and for-cause audits.
• Provide sufficient, appropriate and timely responses to verbal and written queries.
Research Education and Training (5%)
• Participate in the departmental training and orientation program, attend required departmental meetings for training and education.
• Utilize institutional and departmental resources regarding clinical trial conduct.
• Continuously seek learning opportunities and supplemental education.
• Support departmental initiatives.
Other Duties as Assigned (5%)
Working Conditions
• Deadlines - Work environment is deadline focused on the time or date in which a particular task must be finished or a particular assignment, task or function must be done.
• Sedentary Environment - Worker will spend majority of time seated at workstation (frequent 34-66%).
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
Keyboarding
X
EDUCATION
Required: High school diploma or equivalent.
Preferred: Bachelor's degree.
EXPERIENCE
Required: Two years of related experience. With preferred degree, no experience required.
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
The primary purpose of the Coordinator, Research Data is to provide administrative and patient care services for the coordination of clinical research studies.
KEY FUNCTIONS
Data Management (35%)
• Perform data entry and transfer of patient information into electronic databases.
• Review medical records to extract data points.
• Collect, store and maintain accurate and up-to-date source documentation to support data entry.
• Meet contractual agreements for data entry and query resolution timelines; meet external deadlines to support protocol milestones.
• Develop and maintain systems; protocol-specific tools, such as case report forms; and other study materials to control the data flow for single-institution and/or multi-center projects.
• Understand and adhere to the policies and procedures related to conduct of clinical trials as delineated in the institutional policies and department training.
Clinical Research Support (30%)
• Reconcile electronic medical records and source documentation to facilitate accurate patient data reporting consistent with institutional, industry and government standards.
• Prepare clinical trial documents for regulatory compliance.
• Coordinate and prepare weekly updates for protocol review.
• Meet with the Principal Investigator and study team routinely to review study status.
• Alert appropriate individuals regarding upcoming deadlines, meetings, audits, etc.
• Communicate verbally and in-writing with internal and external collaborators to meet study objectives.
Host External Research Personnel (25%)
• Facilitate external research personnel vetting process to comply with institutional and HIPAA requirements.
• Coordinate routine monitoring visits with internal and industry representatives.
• Collaborate with external departments for source document verification.
• Act as a lead contact for protocol data to answer questions and problem solve.
• Support deadlines, routine and for-cause audits.
• Provide sufficient, appropriate and timely responses to verbal and written queries.
Research Education and Training (5%)
• Participate in the departmental training and orientation program, attend required departmental meetings for training and education.
• Utilize institutional and departmental resources regarding clinical trial conduct.
• Continuously seek learning opportunities and supplemental education.
• Support departmental initiatives.
Other Duties as Assigned (5%)
Working Conditions
• Deadlines - Work environment is deadline focused on the time or date in which a particular task must be finished or a particular assignment, task or function must be done.
• Sedentary Environment - Worker will spend majority of time seated at workstation (frequent 34-66%).
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
Keyboarding
X
EDUCATION
Required: High school diploma or equivalent.
Preferred: Bachelor's degree.
EXPERIENCE
Required: Two years of related experience. With preferred degree, no experience required.
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