Supervisor, Clinical Studies / Pediatrics Patient Care
- Requisition #: 173082
- Department: Pediatrics - Patient Care
- Location: Houston, TX
- Posted Date: 2/6/2025
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.
SUMMARY
The primary purpose of the Supervisor, Clinical Studies position is to provide supervision and guidance to the Clinical Study team to ensure the successful performance of the research conducted in Pediatrics-Patient Care.
JOB-SPECIFIC COMPETENCIES
Clinical Protocol Management
Responsible for the effective operation of the department's clinical trials designated by the Director and Administrative Director of Clinical Research.
Provide overall coordination and facilitation of clinical trial treatment for pediatric patients including the coordination, evaluation, and follow-up.
Assign new studies to team members and manage team workload and efficiency. Ensures adequate coverage during time off and holidays.
Collaborate with multidisciplinary teams as necessary.
Act as a liaison with sponsor institutions and pharmaceutical companies conducting research studies.
Attend study initiation meetings to ensure a complete understanding of all roles and responsibilities related to protocol management.
Maintain knowledge of the research process and resources available for efficient management of research projects.
Collaborate with research personnel on conducting site initiation visits. Complete all documentation related to site initiation visits.
Clinical Protocol Activities
Participate in protocol-specific clinical tasks as needed. Guide the clinical studies coordinator on research-related processes for patients when enrolled in research protocols.
Demonstrate clinical competence in aspects of care incorporating institutional guidelines and protocol policies.
Identify, screen, and verify the information for patients that are expected to be enrolled in clinical trial protocols with MDA, the Children's Oncology Group, a consortium, or a pharmaceutical-sponsored clinical trial.
Maintain interface with clinical studies coordinators and other professional personnel to interpret protocol application for a given patient and to answer questions about the study in progress.
Oversee and coordinate data compilation and computation, ensuring quality assurance and compliance with the protocol; review results for validity and reliability and provides initial analyses of results to researchers.
Responsible for ensuring all tests and procedures during the conduct of the study are ordered, completed, and meet protocol guidelines for Good Clinical Practice (GCP) and send reminders as needed.
Coordinate with the clinical nurse to verify good documentation practices pre and post-dose monitoring.
Utilize knowledge of disease processes to observe and report adverse events and protocol violations/deviations in a timely and accurate manner to ensure the health, safety, and welfare of the participant
Act as a liaison for Principal Investigators (PI) and study sponsors to ensure protocol compliance.
Quality Assurance and Auditing
Oversee or execute audit preparation for clinical components. Assign audit preparation activities to team members. Collaborate with research nurses and PI to gather and prepare all relevant documentation.
Work collaboratively with internal and/or sponsor auditors.
Assist in developing and implementing remediation activities in response to audit findings. Execute internal audits of protocols to ensure ongoing quality research oversight.
Maintaining Integrity of Clinical Trials
Independently prepares protocol submissions that comply with regulatory and institutional requirements. Works with study sponsors and/or Clinical Research Organizations (CROs) to facilitate the approval of regulatory documents that conform to both MD Anderson and sponsor requirements.
Facilitates cohesiveness and improves regulatory compliance consistency and integration of departmental goals. Coordinates activities associated with site start-up and overall regulatory management of the studies. Develops and maintains processing and tracking systems for protocol-related documents. Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or sponsor to resolve queries. Prepares and submits various reports to sponsors, investigators, regulatory authorities, Admin Dir, Protocol Research, and any other stakeholders as deemed necessary.
Personnel Management
Develop and maintain a training program for incoming new clinical research team members. Participate in the interview and selection process for clinical research personnel in the assigned area. Effectively evaluate applicants after conducting in-depth and inclusive interviews.
Complete performance evaluations of personnel directly supervised.
Communicate and administer departmental and institutional policy and procedures for personnel in the clinical research area.
Direct and assist clinical studies coordinators and research data coordinators in protocol and patient management by ensuring compliance with all standards, policies, and quality measures.
Establish performance and productivity standards for staff. Ensure the appropriate and maximum utilization of team personnel, provide timely and ongoing performance feedback to maintain required standards, and achieve stated goals.
Coach, mentor, and counsel the team. Implement the disciplinary process within institutional guidelines, if needed. Ensure team attendance at mandatory meetings and compliance with federal, state, and accreditation regulations.
Orient new faculty/support personnel on the department's clinical trials research infrastructure and procedures.
Ensure compliance with Good Clinical Practice (GCP) guidelines.
Attend in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of clinical trials.
Disseminate pertinent information to team members.
Participate in the development of departmental Standard Operating Procedures (SOP), policies, and procedures related to clinical trials.
Assist in the development of educational events for team members. Maintain ongoing knowledge of the clinical trial processes at MD Anderson.
Provide development opportunities and ongoing feedback to employees to include timely completion of administrative staff and classified employees each evaluation period.
Mentor and encourage clinical research staff to develop through participation in professional organizations, serving on committees, and attending journal presentations, seminars, or conferences.
Attend meetings/work responsibilities outside of the set schedule.
Flexibility in work schedule due to operational requirements.
Strategic Planning
Collaborate with leadership in establishing departmental goals, strategies, and procedures in support of operational objectives. Orient new faculty and support personnel on the department's clinical trials research infrastructure and procedures.
Other duties as assigned
REQUIREMENTS
Education: Bachelor's degree in Science, Healthcare, Nursing, or a related field.
Preferred Education: Master's degree in Science, Healthcare, Nursing, or a related field.
Certification: None
Preferred Certification: Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
Experience Required : Six years of experience in the area of research study or direct patient care obtained from nursing, data gathering, or related field. Three years of Supervisory/management experience is preferred.
Preferred Experience: Sr. Clinical Studies Coordinator experience at MD Anderson.
Successful completion of the LEADing Self/Others Accelerate program may substitute for one year of required supervisory or management experience. May substitute required education degree with additional years of equivalent experience on a one-to-one basis.
Onsite Presence: Is 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
Must pass pre-employment skills test as required and administered by Human Resources.
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-Onsite
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.
SUMMARY
The primary purpose of the Supervisor, Clinical Studies position is to provide supervision and guidance to the Clinical Study team to ensure the successful performance of the research conducted in Pediatrics-Patient Care.
JOB-SPECIFIC COMPETENCIES
Clinical Protocol Management
Responsible for the effective operation of the department's clinical trials designated by the Director and Administrative Director of Clinical Research.
Provide overall coordination and facilitation of clinical trial treatment for pediatric patients including the coordination, evaluation, and follow-up.
Assign new studies to team members and manage team workload and efficiency. Ensures adequate coverage during time off and holidays.
Collaborate with multidisciplinary teams as necessary.
Act as a liaison with sponsor institutions and pharmaceutical companies conducting research studies.
Attend study initiation meetings to ensure a complete understanding of all roles and responsibilities related to protocol management.
Maintain knowledge of the research process and resources available for efficient management of research projects.
Collaborate with research personnel on conducting site initiation visits. Complete all documentation related to site initiation visits.
Clinical Protocol Activities
Participate in protocol-specific clinical tasks as needed. Guide the clinical studies coordinator on research-related processes for patients when enrolled in research protocols.
Demonstrate clinical competence in aspects of care incorporating institutional guidelines and protocol policies.
Identify, screen, and verify the information for patients that are expected to be enrolled in clinical trial protocols with MDA, the Children's Oncology Group, a consortium, or a pharmaceutical-sponsored clinical trial.
Maintain interface with clinical studies coordinators and other professional personnel to interpret protocol application for a given patient and to answer questions about the study in progress.
Oversee and coordinate data compilation and computation, ensuring quality assurance and compliance with the protocol; review results for validity and reliability and provides initial analyses of results to researchers.
Responsible for ensuring all tests and procedures during the conduct of the study are ordered, completed, and meet protocol guidelines for Good Clinical Practice (GCP) and send reminders as needed.
Coordinate with the clinical nurse to verify good documentation practices pre and post-dose monitoring.
Utilize knowledge of disease processes to observe and report adverse events and protocol violations/deviations in a timely and accurate manner to ensure the health, safety, and welfare of the participant
Act as a liaison for Principal Investigators (PI) and study sponsors to ensure protocol compliance.
Quality Assurance and Auditing
Oversee or execute audit preparation for clinical components. Assign audit preparation activities to team members. Collaborate with research nurses and PI to gather and prepare all relevant documentation.
Work collaboratively with internal and/or sponsor auditors.
Assist in developing and implementing remediation activities in response to audit findings. Execute internal audits of protocols to ensure ongoing quality research oversight.
Maintaining Integrity of Clinical Trials
Independently prepares protocol submissions that comply with regulatory and institutional requirements. Works with study sponsors and/or Clinical Research Organizations (CROs) to facilitate the approval of regulatory documents that conform to both MD Anderson and sponsor requirements.
Facilitates cohesiveness and improves regulatory compliance consistency and integration of departmental goals. Coordinates activities associated with site start-up and overall regulatory management of the studies. Develops and maintains processing and tracking systems for protocol-related documents. Reviews protocols, amendments, and ancillary documents for discrepancies and/or lack of clarity. Works with PI and/or sponsor to resolve queries. Prepares and submits various reports to sponsors, investigators, regulatory authorities, Admin Dir, Protocol Research, and any other stakeholders as deemed necessary.
Personnel Management
Develop and maintain a training program for incoming new clinical research team members. Participate in the interview and selection process for clinical research personnel in the assigned area. Effectively evaluate applicants after conducting in-depth and inclusive interviews.
Complete performance evaluations of personnel directly supervised.
Communicate and administer departmental and institutional policy and procedures for personnel in the clinical research area.
Direct and assist clinical studies coordinators and research data coordinators in protocol and patient management by ensuring compliance with all standards, policies, and quality measures.
Establish performance and productivity standards for staff. Ensure the appropriate and maximum utilization of team personnel, provide timely and ongoing performance feedback to maintain required standards, and achieve stated goals.
Coach, mentor, and counsel the team. Implement the disciplinary process within institutional guidelines, if needed. Ensure team attendance at mandatory meetings and compliance with federal, state, and accreditation regulations.
Orient new faculty/support personnel on the department's clinical trials research infrastructure and procedures.
Ensure compliance with Good Clinical Practice (GCP) guidelines.
Attend in-services, departmental meetings, mandatory training, and/or other events to remain abreast of new policies/procedures affecting the conduct of clinical trials.
Disseminate pertinent information to team members.
Participate in the development of departmental Standard Operating Procedures (SOP), policies, and procedures related to clinical trials.
Assist in the development of educational events for team members. Maintain ongoing knowledge of the clinical trial processes at MD Anderson.
Provide development opportunities and ongoing feedback to employees to include timely completion of administrative staff and classified employees each evaluation period.
Mentor and encourage clinical research staff to develop through participation in professional organizations, serving on committees, and attending journal presentations, seminars, or conferences.
Attend meetings/work responsibilities outside of the set schedule.
Flexibility in work schedule due to operational requirements.
Strategic Planning
Collaborate with leadership in establishing departmental goals, strategies, and procedures in support of operational objectives. Orient new faculty and support personnel on the department's clinical trials research infrastructure and procedures.
Other duties as assigned
REQUIREMENTS
Education: Bachelor's degree in Science, Healthcare, Nursing, or a related field.
Preferred Education: Master's degree in Science, Healthcare, Nursing, or a related field.
Certification: None
Preferred Certification: Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).
Experience Required : Six years of experience in the area of research study or direct patient care obtained from nursing, data gathering, or related field. Three years of Supervisory/management experience is preferred.
Preferred Experience: Sr. Clinical Studies Coordinator experience at MD Anderson.
Successful completion of the LEADing Self/Others Accelerate program may substitute for one year of required supervisory or management experience. May substitute required education degree with additional years of equivalent experience on a one-to-one basis.
Onsite Presence: Is 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
Must pass pre-employment skills test as required and administered by Human Resources.
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: 173082
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Day/Evening, Days
- Minimum Salary: US Dollar (USD) 75,000
- Midpoint Salary: US Dollar (USD) 93,500
- Maximum Salary : US Dollar (USD) 112,000
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Onsite
- Pivotal Position: No
- Referral Bonus Available?: No
- Relocation Assistance Available?: No
- Science Jobs: No
#LI-Onsite
