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Division Director II

Please see Special Instructions for more details.

The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally and internationally. PHI was distinguished as one of the top 50 “Best Non-profit Organizations to Work For” by the Non-Profit Times in a national search.

Posting Details

Position Information

Posting Number #261-17
Classification Title Division Director II
Position Title #261-17
Associate Director of Research Teams, Data Operations Specialist
Program Areas Research (Program/Project)
Position Summary

PHI is seeking a full-time Associate Director of Research Teams, Data Operations Specialist for the Children’s Oncology Group (COG). This position is located in Monrovia, CA.

The Children’s Oncology Group (COG) is a National Cancer Institute (NCI) supported clinical trials cooperative group, and the world’s largest organization devoted exclusively to childhood and adolescent cancer research. Clinical research is conducted at more than 200 member institutions, which are leading children’s hospitals, universities, and cancer centers throughout the United States, Canada, Europe, Australia, and New Zealand. COG’s over 9,000 multi-disciplinary cancer researchers, affiliated with the network of member institutions, provide access to state-of-the-art therapies and the collective expertise of world-renowned pediatric specialists to children with cancer, regardless of where they live. Today, more than 90% of 14,000 children and adolescents diagnosed with cancer each year in the US are cared for at Children’s Oncology Group member institutions.

COG is primarily supported through cooperative research grants from the NCI. COG also receives funding through other federal and non-federal grants, industry contracts and philanthropic partnerships. With offices in Philadelphia, PA (Children’s Hospital of Philadelphia), Monrovia, California (Public Health Institute) and Gainesville, Florida (University of Florida), COG’s overall annual operating budget is approximately $60M.

Toward its mission of improving treatment by increasing cure rates and reducing side effects, the COG currently conducts Phase I, II, and III active clinical trials and non-therapeutic biology studies, which enroll approximately 9,000 patients annually. COG’s goal is to cure all children and adolescents with cancer, reduce the short and long-term complications of cancer treatments, and determine the causes and find ways to prevent childhood cancer.

An overarching principle of COG is to ensure that the organization’s structure is optimized to maximize the potential for research that improves the outcome for every successive generation of children with cancer.

The Associate Director of Research Teams – Data Operations Specialist will assist the Sr. Director with oversight of the day-to-day activities of a cadre of study teams, and integration/coordination of each team with study chairs, study committees, disease committee chairs, PhD statisticians, and COG core directors. S/he will ensure that study development, implementation and conduct of clinical trials are developed and implemented within specified COG-NCI timelines.

The Associate Director of Research Teams – Data Operations Specialist in collaboration with the Sr. Director will support the direction and management of study teams that are composed of members responsible for development, implementation and conduct of Children’s Oncology Group (COG) research protocols. As COG is a matrix organization, the Associate Director of Research Teams – Data Operations Specialist will work with the Sr. Director of Research Teams, Data Operations Specialist to set and maintain standards for all research coordinators and Rave programmers within the organization and oversee functions related to data acquisition and quality control.

PHI Introduction

The Public Health Institute (PHI) is an independent, nonprofit organization dedicated to promoting health, well-being and quality of life for people throughout California, across the nation and around the world. As one of the largest and most comprehensive public health organizations in the nation, we are at the forefront of research and innovations to improve the efficacy of public health statewide, nationally and internationally. PHI was distinguished as one of the top 50 “Best Non-profit Organizations to Work For” by the Non-Profit Times in a national search.

Duties & Responsibilities

Duties & Responsibilities:

  • Project manage all trials in the league from concept through publication.
  • Monitor workloads and provide day-to-day oversight of team members supporting the operations of COG clinical trials.
  • Establish training plans for new league staff and provide and coordinate necessary training.
  • Resolve problems by consulting the league’s Senior Director, study committees, lab directors, COG leadership, other Senior Directors, Associate Directors or Core Operations Directors.
  • Develop and implement strategies to maintain consistency across all COG teams and disease committees with regard to all trial operations
  • In collaboration with the league’s Senior Director, provide direction to administrative support staff.
  • Write and maintain standard operating procedures that govern case report form (CRF) development in Medidata Rave as well as the conduct and data management of existing studies in legacy data systems and in Medidata Rave.
  • Coordinate the creation of standardized CRF templates for use across all COG studies as well as disease-specific CRF templates.
  • Supervise the creation of data elements by RCs as needed to capture essential research data for COG studies.
  • Ensure that research coordinator and RAVE Builder collaboration includes clear communication and hand-off plans to ensure that trial development and conduct is not compromised.
  • Oversee and monitor research coordinators’ implementation of systems for rapid tracking and reporting of toxic deaths, severe adverse events (SAEs), treatment failures, or other critical study endpoints, as appropriate for all COG studies.
  • Ensure all trial related activities must be carried out in accordance with COG and NCI Standard Operating Procedures (SOPs) and the relevant Federal, State and Good Clinical Practices (GCP) regulations.
  • Author sections of grant applications addressing data operations
  • Contribute to performance reviews of team staff.
  • Attend semi-annual Group meetings and participate in relevant committee meetings, presenting to committees and group membership as needed.
  • Manage other day-to-day operational tasks at the discretion of the Senior Director.
  • Participate in COG leadership conferences and strategic planning.
Minimum Qualifications

Qualifications:

  • Bachelor’s degree or higher in a science-related field or equivalent relevant experience. Graduate degree preferred.
  • 5 years data operations/clinical trials experience
  • Excellent interpersonal skills and demonstrated ability to supervise and manage a multi-disciplinary team.
  • Excellent written and oral communications skills.
  • Goal/results oriented with proactive approach to problem-solving.
  • Proven experience in managing multiple projects within a network environment.
  • Critical thinking and reasoning
  • Experience in electronic data capture (EDC), database design, development and implementation is highly desirable.
  • Experience in a comprehensive cancer center, a cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
  • Experience with Medidata Rave or similar clinical trial management system is preferred.
  • Must be familiar with essential FDA regulations governing clinical trials
  • Knowledge of oncology research is preferred.
Compensation

Compensation:

This is an exempt position and the salary is commensurate with experience. PHI offers a generous benefits package including medical, dental, vision, short/long term disability insurance, life insurance, 403b (group retirement annuity) and partial subsidy of public transportation cost. For more information about PHI’s benefits, visit our benefits page here.

Open Date 12/06/2017
Close Date
Open Until Filled Yes
Location Monrovia
CA

Supplement Questions

Required fields are indicated with an asterisk (*).

  1. * Do you have the required education?
    • Yes
    • No
  2. * Do you have the required years of experience?
    • Yes
    • No
  3. * Do you have the necessary skills to perform this position?
    • Yes
    • No
  4. * Do you have 5 years of data operations experience?
    • Yes
    • No
  5. * Do you have 5 years of clinical data experience?
    • Yes
    • No
  6. * Do you have Medidata Rave experience?
    • Yes
    • No
  7. * Do you have 5 years of clinical trials operations?
    • Yes
    • No

Applicant Documents to Attach

Required Documents
  1. Resume
  2. Cover Letter
Optional Documents