Regulatory Project Manager
Yale Cancer Center Clinical Trials Office
Direct link to apply: http://bit.ly/65421BR
About the Yale Cancer Center Clinical Trials Office (CTO)
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 open and enrolling clinical trials and over 600 open clinical trials, providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education.
Reporting to the Senior Regulatory Project Manager, the Regulatory Project Manager is tasked with maintaining quality control functions and monitoring compliance for research studies supported by the regulatory affairs department and involved with proactively addressing issues to ensure overall integrity in document management through quality and compliance checks. Working collaboratively with key stakeholders within YCC Clinical Trials Office (CTO), as well as colleagues across the YCC research enterprise, this role will oversee assigned service lines (workflow processes) and track regulatory activation milestones and timelines, promoting timely and compliant opening of new studies, in addition to providing administrative oversight of clinical trials by actively monitoring approvals, document creation, sponsor relationships, and overall study management from a regulatory perspective.
Supervise day to day work activities of assigned regulatory staff, including delegation of work units and managing staff workload through communication of job expectations, planning, monitoring, and evaluation of work product.
Provide quality reviews and oversight functions for all institutional review board (IRB) submissions and post-approvals to ensure regulatory integrity, while evaluating submission metrics and staff feedback to identify gaps in efficiency.
Manage regulatory compliance activities related to quality control, including audit preparation, responses related to regulatory findings, reportable events, corrective actions, and other special projects related to efficiency and compliance within the regulatory department.
Under direction of the Senior Regulatory Project Manager, develop new regulatory policies, processes and SOPs/guidance documents, and evaluate existing policies and procedures by performing quality control checks and collaborating with University quality assurance personnel.
Conduct and assist in leading regulatory quality control activities for Investigator-Initiated, Industry sponsored, and national Cooperative group studies.
Conduct ongoing quality reviews of regulatory binders and study related activities in preparation for internal and external audits and/or inspections.
Maintain regulatory compliance and project management for single-center Investigator-Initiated Clinical Trials where the IND is held by a Yale Investigator. Liaise with IND Coordinator to ensure compliance with Code of Federal Regulations.
Identify resource requirements for pipeline protocols and forecast logistical issues that affect regulatory compliance.
Facilitate and track data with the flow of pipeline protocols throughout the start-up process. Identify regulatory obstacles to study activation and propose improvements to the process, analyze activation barriers, and report to senior research leadership activation metrics, potential roadblocks to success, and corrective actions.
Perform staff coaching, mentoring, progressive counseling, and disciplining, as needed. Provide performance feedback and performance management as indicated.
Participate in and lead structured meetings including (but not limited to) Regulatory Staff Meetings, education for Regulatory Staff, and special project sessions which facilitate communication, knowledge dissemination, process improvement, and general regulatory topics.
Maintain and advance professional knowledge on appropriate regulations and processes related to regulatory compliance in clinical trials, as well as attend educational workshops, review professional publications, and disseminate knowledge to group.
Apply strong attention to detail in all aspects of regulatory work.
Other duties as assigned.
Required Education and Experience
Bachelor’s Degree in related field and three years of related experience or an equivalent combination of education and experience.
Required Skill/Ability 1:
Ability to lead regulatory personnel in a large, multi-study oncology-specific workload portfolio and assure compliance with regulatory agencies.
Required Skill/Ability 2:
Ability to prioritize the oncology-specific workload of a large, multi-study portfolio, with multiple DART-specific responsibilities.
Required Skill/Ability 3:
Ability to maintain compliant processes and workflows supporting a large, multi-study oncology protocol portfolio. Ability to participate in and help lead quality control and educational efforts within a large oncology regulatory department. Strong attention to detail and quality in document and form submission.
Required Skill/Ability 4:
Ability to interface with, communicate, and provide a large volume of compliant submissions for protocol activation and ongoing compliance to the oncology specific committees which govern Yale Cancer Center Human Subject research studies.
Required Skill/Ability 5:
Ability to motivate, develop, and assess learning capacity of direct reports, as well as identify opportunities to assess quality, efficiency, and implement process improvement in regulatory activities when necessary.
Preferred Education, Experience and Skills:
A minimum of a BA/BS degree or equivalent with 5 years regulatory experience (e.g., research, clinical, interaction with study population, program coordination) and 3 years supervisory experience. Advanced knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations.
Preferred Licenses or Certifications:
ACRP/SoCRA (or equivalent) certification preferred; Masters level preparation preferred.
Working at Yale
Yale University offers exciting opportunities for achievement and growth in New Haven, Connecticut. Conveniently located between Boston and New York, New Haven is the creative capital of Connecticut with cultural resources that include three major museums, a critically-acclaimed repertory theater, state-of-the-art concert hall, and world-renowned schools of Architecture, Art, Drama, and Music.
We invite you to discover the excitement, diversity, rewards and excellence of a career at Yale University. One of the country's great workplaces, Yale University offers exciting opportunities for meaningful accomplishment and true growth. Our benefits package is among the best anywhere, with a wide variety of insurance choices, liberal paid time off, fantastic family and educational benefits, a variety of retirement benefits, extensive recreational facilities, and much more.
Affirmative Action Statement
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression.