Address
Form of workSUMMARY
The primary purpose of the Senior Coordinator, Clinical Studies position is to collaborate with the research team and Principal Investigator (PI) to coordinate clinical trial subject accrual and data management activities for the Division of Diagnostic Imaging.
MISSION STATEMENT
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
ADMINISTRATIVE
• Assists with the development process of research data management staff.
• May be asked to provide coverage for key functions and/or at relevant meetings for the research team.
CLINICAL TRIAL MANAGEMENT
• In consultation with the physician and/or research nurse, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols.
• Comprehends protocol and in collaboration with a Research Nurse or Research Nurse, Supervisor, develops systems for screening patients. Assists/create source document templates and other documents as needed for protocols.
• In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood, signed, and processed appropriately.
• Consults with principal investigator (PI) and/or Mgr., Clinical Protocol Administration regarding ongoing clinical trial assignments. Works closely with the research team to ensure consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation. As needed, obtains patient charts and outside documents required for protocol compliance.
• Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires face-to-face interaction with patients. Requires ability to gather relevant information and determine the appropriate information to report. Requires accurate and prompt patient documentation in the patient's medical record.
• Knowledge of protocol databases and electronic applications; proficient in the use of Microsoft office applications and departmental/Institutional electronic data systems.
• Communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, protocol status, and other events.
• Schedules and participates in routine monitoring. Provides sufficient, appropriate, and timely responses to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and federal clinical trial audits.
• Preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and manuscripts as required by the department.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE
• Attends appropriate departmental meetings and institutional continuing education programs
• Plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies.
• Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
• Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
• Other duties as assigned.
Required education: Bachelor's degree.
Required experience: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years 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
#LI-Hybrid
The primary purpose of the Senior Coordinator, Clinical Studies position is to collaborate with the research team and Principal Investigator (PI) to coordinate clinical trial subject accrual and data management activities for the Division of Diagnostic Imaging.
MISSION STATEMENT
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
ADMINISTRATIVE
• Assists with the development process of research data management staff.
• May be asked to provide coverage for key functions and/or at relevant meetings for the research team.
CLINICAL TRIAL MANAGEMENT
• In consultation with the physician and/or research nurse, assesses patients for eligibility through personal interviews and medical record review. Responsible for accurate and successful patient recruitment to assigned protocols.
• Comprehends protocol and in collaboration with a Research Nurse or Research Nurse, Supervisor, develops systems for screening patients. Assists/create source document templates and other documents as needed for protocols.
• In collaboration with the Principal Investigator (PI), responsible for ensuring the consent is understood, signed, and processed appropriately.
• Consults with principal investigator (PI) and/or Mgr., Clinical Protocol Administration regarding ongoing clinical trial assignments. Works closely with the research team to ensure consistency between protocol database and source documentation; includes generating written queries for missing/deficient source documentation. As needed, obtains patient charts and outside documents required for protocol compliance.
• Responsible for accurate and timely transcription of study data to paper and/or electronic Case Report Form (CRF), retrieving information from electronic record, chart, and/or phone call. Requires face-to-face interaction with patients. Requires ability to gather relevant information and determine the appropriate information to report. Requires accurate and prompt patient documentation in the patient's medical record.
• Knowledge of protocol databases and electronic applications; proficient in the use of Microsoft office applications and departmental/Institutional electronic data systems.
• Communicates routinely with intradepartmental, extramural, and industry research collaborators regarding queries, data entry, database issues, protocol status, and other events.
• Schedules and participates in routine monitoring. Provides sufficient, appropriate, and timely responses to sponsor queries. Participates with activities ensuring preparedness for industry, institutional, and federal clinical trial audits.
• Preparation of quality reports and metrics for the purpose of grant submissions, budget creation, clinical trial evaluations, protocol review presentations, data review events, audits, conferences, posters, and manuscripts as required by the department.
MAINTAINS A LEVEL OF PROFESSIONAL EXPERTISE
• Attends appropriate departmental meetings and institutional continuing education programs
• Plans, designs, and conducts complex professional and ancillary education sessions to ensure dissemination of new information and policies.
• Demonstrates excellent oral and written communication skills when contacting other institutions, patients and agencies (i.e. NCI, pharmaceutical companies, sponsoring agencies, etc.) by phone, email and/or face to face interactions. Assimilates pertinent information in order to compose written correspondence.
• Maintains working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines as well as a comprehensive understanding of the research trial process, including but not limited to eligibility and disease processes.
• Other duties as assigned.
Required education: Bachelor's degree.
Required experience: Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years 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: 162291
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 61,500
- Midpoint Salary: US Dollar (USD) 77,000
- Maximum Salary : US Dollar (USD) 92,500
- 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
