Associate Director Clinical Trials Regulatory - MD Anderson
Houston, TX
About the Job
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.
The position is responsible for providing regulatory oversight needed for drafting applicable study documents, including protocol and informed consent. Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintaining Regulatory database accordingly. Manage regulatory support staff in the management of protocol-related activities such as regulatory start-up and consent writing/editing. Supervise team members responsible for editing of all new and revised informed consent documents, and the centralized regulatory start up team.
JOB SPECIFIC COMPETENCIES
70% Regulatory Operations
· Oversees the consent writing and regulatory start-up process of clinical research trials for all MDA departments participating in Phase I-V clinical trials.
· Communicates verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
· Ensure that all clinical trials comply with applicable regulatory requirements, including ICH GCP, FDA and EMA regulations.
· Monitor changes in regulatory requirements and communicate their impact on ongoing and future clinical trials.
· Collaborate with the Quality Assurance team to ensure adherence to regulatory standards and best practices.
· Provide regulatory expertise to cross-functional teams and contribute to the development of clinical and regulatory documents (e.g., protocols, informed consent forms, clinical study reports).
· Collaborate with senior management to establish and adhere to timelines and goals.
· Manages electronic consent system, ensuring timely and accurate document availability.
· Serves as a regulatory expert for clinical research departments and external entities.
20% Training
· Supervises the consent writing and regulatory start-up teams.
· Oversees staff training on institutional systems required for study submission through activation (e.g. OneIRB, OnCore, eReg, etc.)
· Develops, implements, and executes new clinical trial research processes to ensure local and federal regulatory compliance.
· Oversees training programs to ensure compliance with all institutional standards.
· 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.
10% Planning and Reporting
· Develops and maintains a processing and tracking systems for protocol related paperwork.
· Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for clinical trials.
· Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.
· Oversees the effective operation of clinical trials in collaboration with the principal investigator and the study sponsor.
Other duties as assigned
Required Qualifications
Preferred Education: Master's Degree
Preferred Certification:
One of the following:
Certified Institutional Review Board Professional (CIP)
Certified Institutional Review Board Manager (CIM)
Certified Clinical Research Professional (CCRP)
Certified Clinical Research Associate (CCRA)
Preferred Experience: Six years of experience in a regulatory professional healthcare setting including consent form writing and editing. Experience to include three years of supervisory/management 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-Remote
The position is responsible for providing regulatory oversight needed for drafting applicable study documents, including protocol and informed consent. Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintaining Regulatory database accordingly. Manage regulatory support staff in the management of protocol-related activities such as regulatory start-up and consent writing/editing. Supervise team members responsible for editing of all new and revised informed consent documents, and the centralized regulatory start up team.
JOB SPECIFIC COMPETENCIES
70% Regulatory Operations
· Oversees the consent writing and regulatory start-up process of clinical research trials for all MDA departments participating in Phase I-V clinical trials.
· Communicates verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
· Ensure that all clinical trials comply with applicable regulatory requirements, including ICH GCP, FDA and EMA regulations.
· Monitor changes in regulatory requirements and communicate their impact on ongoing and future clinical trials.
· Collaborate with the Quality Assurance team to ensure adherence to regulatory standards and best practices.
· Provide regulatory expertise to cross-functional teams and contribute to the development of clinical and regulatory documents (e.g., protocols, informed consent forms, clinical study reports).
· Collaborate with senior management to establish and adhere to timelines and goals.
· Manages electronic consent system, ensuring timely and accurate document availability.
- Interprets, and applies FDA regulations, NCI policies/procedures, and Good Clinical Practice guidelines while reviewing protocols, informed consents, and all related documents.
· Serves as a regulatory expert for clinical research departments and external entities.
20% Training
· Supervises the consent writing and regulatory start-up teams.
· Oversees staff training on institutional systems required for study submission through activation (e.g. OneIRB, OnCore, eReg, etc.)
· Develops, implements, and executes new clinical trial research processes to ensure local and federal regulatory compliance.
· Oversees training programs to ensure compliance with all institutional standards.
· 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.
10% Planning and Reporting
· Develops and maintains a processing and tracking systems for protocol related paperwork.
· Creates, updates, and maintains organizational files which include all pertinent correspondence and information regarding regulatory activities for clinical trials.
· Maintains an up-to-date status report and creates summary reports as requested for supervisor, PI, and/or management staff.
· Oversees the effective operation of clinical trials in collaboration with the principal investigator and the study sponsor.
Other duties as assigned
Required Qualifications
- Bachelor's Degree Nursing, Business, Healthcare Administration, or related field. Required
- 6 years Healthcare setting to include three years research management and regulatory compliance. Required
- Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.
Preferred Education: Master's Degree
Preferred Certification:
One of the following:
Certified Institutional Review Board Professional (CIP)
Certified Institutional Review Board Manager (CIM)
Certified Clinical Research Professional (CCRP)
Certified Clinical Research Associate (CCRA)
Preferred Experience: Six years of experience in a regulatory professional healthcare setting including consent form writing and editing. Experience to include three years of supervisory/management 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: 172604
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 119,500
- Midpoint Salary: US Dollar (USD) 149,500
- Maximum Salary : US Dollar (USD) 179,500
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Hard
- Work Location: Remote
- Pivotal Position: Yes
- Referral Bonus Available?: Yes
- Relocation Assistance Available?: Yes
- Science Jobs: Yes
#LI-Remote
Source : MD Anderson