Associate Director of Research Teams, Trial Operations Specialist
Posting Number: #129-21
Position Title: Associate Director of Research Teams, Trial Operations Specialist
Closing Date: Until Filled
Location: Monrovia, CA
Children’s Oncology Group (COG), a project of PHI, 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 – Trial Operations Specialist will assist the Executive Directors of Clinical Research Operations and Data Operations with oversight of the day-to-day activities of a cadre of study teams, and integration/coordination of each team with the study chair, study team, disease committee chair, 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 – Trial Operations Specialist in collaboration with the Executive Directors of Clinical Research Operations and Data Operations 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 – Trial Operations Specialist will work as part of the Trial Operations Leadership Group on setting and maintaining standards for all protocol coordinators within the organization. Protocol coordinators are members of study teams that work with physicians/scientists to assist in writing, developing and producing final versions of clinical research protocols.
Essential Duties & Responsibilities
- Project manage all trials in the league from concept through publication.
- Supervise league staff on assigned teams.
- 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 Executive Directors, provide direction to administrative support staff.
- Write and maintain standard operating procedures specific to protocol development across teams.
- In collaboration with the Executive Director of Clinical Research Operations, create tools/processes for new Study Chairs and study committee members to assist in the development of consistent, standardized protocols, manuals of operation and training materials.
- Review all COG Scientific Council review comments, NCI review comments and Pediatric Central IRB stipulations with the goal of maintaining consistency across protocols and consents.
- Maintain protocol and consent templates, as well as disease-specific protocol section templates.
- Monitor all study-related communication and protocol amendments to identify opportunities for process improvement in how protocols are written and study-related communications are drafted.
- 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 trial operations.
- Complete and administer performance reviews for direct reports, and contribute to performance reviews of other league staff as applicable.
- 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 Executive Director.
- Participate in COG leadership conferences and strategic planning.
- 7 years of relevant experience, including 3 years of management-level experience preferred. Knowledge/experience related to leadership can substitute.
- 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 communication skills.
- Goal/results-oriented with a proactive approach to problem-solving.
- Proven experience in managing multiple projects within a network environment.
- Critical thinking and reasoning.
- Must be familiar with essential FDA regulations governing clinical trials.
- Bachelor’s degree or higher in a science-related field or equivalent relevant experience.
- Scientific writing or editing experience highly desirable.
- Experience obtaining clinical trial protocols reviewed and approved by Institutional Review Boards (IRBs) preferred.
- Experience in a comprehensive cancer center, a cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
- Knowledge of oncology research is preferred.
- Graduate degree preferred.
- This is a full-time (40 hours/week) position.
- To qualify for this position, applicants must be legally authorized to work in the United States.
The Public Health Institute is committed to a policy that provides equal employment opportunities to all employees and applicants for employment without regard to race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and to make all employment decisions so as to further this principle of equal employment opportunity. To this end, the PHI will not discriminate against any employee or applicant for employment because of race, color, sex, religion, national origin, ancestry, age, marital status, pregnancy, medical condition including genetic characteristics, physical or mental disability, veteran status, gender identification and expression, sexual orientation, and will take affirmative action to ensure that applicants are offered employment and employees are treated during employment without regard to these characteristics.
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We’re so pleased the Public Health Institute is an organization you would like to work with. Do you have questions about this opportunity? If so, email our recruitment team at Recruitment@phi.org.