Clinical Research Monitor - MultiCenter
MD Anderson
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 Clinical Research Monitor will be responsible for the review and evaluation of multicenter clinical trial conduct to ensure compliance of the clinical research study to the protocol, ICH-GCP guidelines, FDA regulations and applicable policies/standard operating procedures. The position will be responsible for providing education to site personnel and performing study monitoring activities.
KEY FUNCTIONS
Performs monitoring activities and assesses the conduct of clinical trials to ensure compliance with CFR, ICH-GCP guidelines and applicable policies/standard operating procedures.
Ensures the rights and well-being of human subjects are safeguarded and comply with regulatory requirements and institutional policies relating to human subject research.
Develops and maintains highly collaborative working relationships with internal teams, investigators and study staff.
Participates in the development of and/or review of study related documents (Protocol, Informed Consent, CRFs, Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).
Participates in/leads site initiation meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in accordance with the protocol.
Manages monitoring schedules for assigned studies and ensures timely completion of monitoring activities and reports.
Conducts qualification visits, site initiation visits, monitoring visits and close-out visits, performs data review and monitors data quality. Generates visit/data review reports summarizing findings and liaises with study site personnel to ensure timely query and action item resolution.
Escalates study issues to the Clinical Trial Project Director/Senior Management and Principal Investigator in a timely manner. Notifies investigators of any safety or human subject's protection related findings.
Utilizes critical thinking to review the completeness of patient assessments and determine if patient care is provided according to protocol requirements.
Reviews records to ensure research related evaluations and tests are conducted in accordance with the protocol and regulatory requirements.
Reviews safety reports and toxicity assessments related to protocol care. Identifies and communicates with sites regarding any follow-up of Serious Adverse Events (SAEs) at study sites.
Communicate relevant information and findings both verbally and through formal written reports.
Responsible for educating and training of research staff and communicating directly with investigative sites to provide guidance and answer questions for successful outcomes.
Attends and coordinates project meetings and/or trainings as required.
Reports study activities to the Clinical Trial Project Director to ensure project milestones and timelines are maintained.
Assists in preparing sites for audits or inspections and assists with audit responses.
Assists in the development of standard operating procedures, guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.
Champions and fosters a high-quality culture within the department.
Other duties as assigned.
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
EDUCATION
Required:
Bachelor's degree in Nursing, Healthcare Administration or related field
Preferred:
Advanced degree
EXPERIENCE
Required:
Four years clinical experience, to include at least two years of clinical research.
Preferred:
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS.
One year auditing experience and one year monitoring experience.
Strong, in-depth knowledge of FDA regulations and ICH/GCP.
Demonstrated ability to manage multiple multicenter studies.
Proficiency with Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project, Visio).
LICENSURE / CERTIFICATION
Preferred:
Certified Clinical Research Professional (CCRP), or Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) or Advanced Oncology Certified Nurse (AOCN) or Oncology Certified Nurse (OCN) or Regulatory Affairs Professional (RAP).
OTHER
Required:
Must pass pre-employment test as required and administered by Human Resources.
Additional Information
Requisition ID: 173396 Employment Status: Full-Time Employee Status: Regular Work Week: Days Minimum Salary: US Dollar (USD) 86,000 Midpoint Salary: US Dollar (USD) 107,500 Maximum Salary : US Dollar (USD) 129,000 FLSA: exempt and not eligible for overtime pay Fund Type: Hard Work Location: Hybrid Onsite/Remote Pivotal Position: No Referral Bonus Available?: No Relocation Assistance Available?: No Science Jobs: No
#LI-Hybrid Apply
SUMMARY
The Clinical Research Monitor will be responsible for the review and evaluation of multicenter clinical trial conduct to ensure compliance of the clinical research study to the protocol, ICH-GCP guidelines, FDA regulations and applicable policies/standard operating procedures. The position will be responsible for providing education to site personnel and performing study monitoring activities.
KEY FUNCTIONS
Performs monitoring activities and assesses the conduct of clinical trials to ensure compliance with CFR, ICH-GCP guidelines and applicable policies/standard operating procedures.
Ensures the rights and well-being of human subjects are safeguarded and comply with regulatory requirements and institutional policies relating to human subject research.
Develops and maintains highly collaborative working relationships with internal teams, investigators and study staff.
Participates in the development of and/or review of study related documents (Protocol, Informed Consent, CRFs, Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.).
Participates in/leads site initiation meetings, ensuring the study staff conducting the study have received the proper materials, instructions and training to safely and accurately conduct the study in accordance with the protocol.
Manages monitoring schedules for assigned studies and ensures timely completion of monitoring activities and reports.
Conducts qualification visits, site initiation visits, monitoring visits and close-out visits, performs data review and monitors data quality. Generates visit/data review reports summarizing findings and liaises with study site personnel to ensure timely query and action item resolution.
Escalates study issues to the Clinical Trial Project Director/Senior Management and Principal Investigator in a timely manner. Notifies investigators of any safety or human subject's protection related findings.
Utilizes critical thinking to review the completeness of patient assessments and determine if patient care is provided according to protocol requirements.
Reviews records to ensure research related evaluations and tests are conducted in accordance with the protocol and regulatory requirements.
Reviews safety reports and toxicity assessments related to protocol care. Identifies and communicates with sites regarding any follow-up of Serious Adverse Events (SAEs) at study sites.
Communicate relevant information and findings both verbally and through formal written reports.
Responsible for educating and training of research staff and communicating directly with investigative sites to provide guidance and answer questions for successful outcomes.
Attends and coordinates project meetings and/or trainings as required.
Reports study activities to the Clinical Trial Project Director to ensure project milestones and timelines are maintained.
Assists in preparing sites for audits or inspections and assists with audit responses.
Assists in the development of standard operating procedures, guidelines, intradepartmental procedures, and other continuous process improvements programs, as assigned.
Champions and fosters a high-quality culture within the department.
Other duties as assigned.
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
EDUCATION
Required:
Bachelor's degree in Nursing, Healthcare Administration or related field
Preferred:
Advanced degree
EXPERIENCE
Required:
Four years clinical experience, to include at least two years of clinical research.
Preferred:
Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS.
One year auditing experience and one year monitoring experience.
Strong, in-depth knowledge of FDA regulations and ICH/GCP.
Demonstrated ability to manage multiple multicenter studies.
Proficiency with Microsoft Office suite (Word, Excel, PowerPoint, Outlook, Project, Visio).
LICENSURE / CERTIFICATION
Preferred:
Certified Clinical Research Professional (CCRP), or Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) or Advanced Oncology Certified Nurse (AOCN) or Oncology Certified Nurse (OCN) or Regulatory Affairs Professional (RAP).
OTHER
Required:
Must pass pre-employment test as required and administered by Human Resources.
Additional Information
Requisition ID: 173396 Employment Status: Full-Time Employee Status: Regular Work Week: Days Minimum Salary: US Dollar (USD) 86,000 Midpoint Salary: US Dollar (USD) 107,500 Maximum Salary : US Dollar (USD) 129,000 FLSA: exempt and not eligible for overtime pay Fund Type: Hard Work Location: Hybrid Onsite/Remote Pivotal Position: No Referral Bonus Available?: No Relocation Assistance Available?: No Science Jobs: No
#LI-Hybrid Apply
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