Clinical Trial Monitoring Manager-Remote

Location
Monrovia, California
Salary
Competitive
Posted
November 06 2021
Ref
10013893
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

The Manager for Clinical Trial Monitoring provides consistent leadership as well as operational and general oversight of City of Hope's Clinical Trial Monitoring and to ensure competent and standardized practices that are compliant with all institutional and regulatory requirements. The Manager supervises, monitors and supports the administration and progress of City of Hope led clinical research conducted at multiple institutions.

Additionally, the Manager is responsible for the management and oversight for the clinical trial planning, implementation and monitoring for City of Hope investigator-initiated trials. The Manager will develop, execute and manage City of Hope's monitoring program to ensure adequate monitoring is performed on investigator initiated clinical trials. The Manager will also be responsible for maintaining monitoring program that contributes to the success of clinical trials conducted at City of Hope from the standpoint of regulatory requirements, Good Clinical Practice, data quality, protocol compliance, and protection of human subjects.

The Manager is expected to collaborate closely with the Director of Safety and Data Quality in developing standard procedures, tools and systems, as well as tracking metrics. They will also provide assistance to Office of IND Development and Regulatory Affairs (OIDRA) for studies with COH INDs with providing information about the sites, and reported AEs, SAEs, or UPs and any regulatory documents that are needed for the FDA. The leadership team in the Clinical Trials Office (CTO) will work with the Manager to develop guidelines and tools to assist in protocol compliance and data collection. The Manager is expected to collaborate closely with other managers and directors throughout Research Operations and City of Hope including Clinical Trial Support Services (CTSS) to provide appropriate guidance on budgets and contracts upon

Key Responsibilities include:
  • Responsible for the supervision, onboarding and training of Clinical Research Associates (CRA) with in the Office of Clinical Trials Monitoring (OCTM).
  • Serve as resource for issues related to monitoring findings.
  • Accountable for the execution of monitoring plans (including implementing a risk based monitoring approach) and overall quality of monitoring performed by clinical trial monitors.
  • Create monitoring report templates, tools and work instructions, and identify ways to streamline work processes and support quality improvement initiatives.
  • Participate in FDA inspection and other external sponsor readiness plans and activities.
  • Identifies areas requiring follow-up and improvement at COH and participating centers. Recommends corrective action. Follows up on action items to ensure completion.
  • Review all monitoring reports prior to distribution and attend all investigator meetings with clinical trial monitors.
  • Provides ongoing review of common findings to completion of root cause analysis of common deficiencies.
  • Prepares presentations to or reports to communicate summary findings and recommendations.
  • Responsible for the development of departmental and institutional SOPs that are aligned with regulatory policies and best practices.
  • Keep abreast of new internal and external developments related to the conduct, management and monitoring of multicenter research. Serve as an institutional resource for the complete and correct application of federal regulations, NIH guidelines and industry best practices for the start-up and monitoring of multicenter research. Assess COH practices for alignment with federal regulations, accreditation standards, and best practices related to the conduct of multicenter research.
  • Significantly contributes to the CCSG Competitive Grant Renewal submission, the annual progress reports for the Clinical Protocol & Data Management section as well as material for Cancer Center External Advisory Committee Meetings. Responsible for developing materials and support the NCI site visits as needed.
  • Serves as a subject matter expert to provide feedback on study-related documents, including (but not limited to), study protocol, informed consent template, Manual of Procedures, Case Report Forms, especially when protocols are transitioning from single-center to multi-center.
  • Use established metrics, and participate in the development of new metrics. Use quantitative and qualitative metrics, along with various forms of stakeholder feedback, to identify performance improvement opportunities and implement process improvements.
  • Participates in ongoing clinical research performance improvement initiatives.
  • Ensures that sites have system access to the systems they need to complete registration and case report forms, as well as managing the studies at their sites.


Basic education, experience and skills required for consideration:
  • Bachelor's degree is required.
  • Six or more years of experience in clinical research conduct, administration and/or management, preferably in a NCI-designated Comprehensive Cancer Center or academic medical center. At least 4 years of experience providing direction on interpreting federal, state, and sponsor policies and regulations in a clinical research setting required.
  • 1 year of experience in a lead/supervisory capacity.

Preferred education experience and skills:
  • Degree in biological, health sciences or related field is preferred.
  • Certification through SoCRA or ACRP.
  • Prefer experience in clinical research settings, ideally cancer trials.

Skills/Abilities:
  • In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e.
  • Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
  • Strong Communication and interpersonal skills, including good command of English Language.
  • Strong organizational and problem-solving skills.
  • Good team leadership skills; effective mentoring and training skills.
  • Ability to manage competing priorities.

Additional Information:
  • To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.

City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability. #LI-G

  • Posting Date: Nov 5, 2021
  • Job Field: Clinical Research
  • Employee Status: Regular
  • Shift: Day Job

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