Reporting to the Regulatory Manager, the Senior Regulatory Affairs Specialist plays a key role in the research and treatment mission of Yale Cancer Center Clinical Trials Office (“CTO”) by managing the study portfolio and independently executing regulatory activities for all types of clinical research studies across the lifecycle of the protocol from activation to closeout. The Senior Regulatory Affairs Specialist will be aware of and take a leadership role in implementing changes due to updates to regulations and policies governing clinical research and planning for the regulatory aspects of growth to support the research enterprise. The Senior Regulatory Affairs Specialist is responsible for regulatory start-up of new protocols, including providing regulatory expertise in the development, preparation, submission, and management of complex federally regulated YCC Investigator-Initiated and multisite trials. This role will interface with faculty and department staff across the organization, as well as identify and define logistics, action items or information needed to maintain regulatory affairs support, as well as create and foster a collaborative, positive relationship with internal staff and external organizations. The Senior Regulatory Affairs Specialist oversees and makes decisions or commitments that require interpretation and analysis of federal research regulations, Good Clinical Practice and the institution's policies and procedures. The Senior Regulatory Affairs Specialist will monitor workload intensity and track deadlines within their disease team’s assigned portfolio and ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting key performance metrics for CTO leadership and departmental stakeholders. The Senior Regulatory Affairs Specialist collaborates closely with their team, management, and provides leadership and mentorship to Regulatory Affairs Specialists 1 and 2. This role identifies growth opportunities and further efficiencies that impact the disease program and/or department’s success. The Senior Regulatory Affairs Specialist interfaces with key stakeholders to maintain and further develop disease program growth, as well as relationship building and maintenance.
1. Serves as the primary specialist on regulatory affairs processes for all types of clinical research studies, including high acuity trials. 2. Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. Provides critical input into modified workflows and policies to address changes. 3. Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and responses at time of study initiation, execution/maintenance and close out. Interprets and applies regulations, policies and procedures to advise others on regulatory and compliance matters. 4. Utilizes regulatory expertise and employs regulatory strategy to provide technical review of and draft required reports and makes recommendations based on analysis of the protocol and knowledge of clinical trials, operations, and ICH Good Clinical Practices, federal regulations, and institutional processes. 5. Facilitates communication between PI, study team and University key stakeholders to support regulatory activities for applicable studies. 6. Oversees the maintenance of attributable, legible, contemporaneous, original, accurate and complete regulatory documentation to substantiate the essential documents for all trial types, including highly acuity clinical research trials. 7. Identifies instances of noncompliance and deviations from the protocol and regulatory requirements. Oversees and prepares reports to the appropriate parties and committees. 8. Analyzes regulatory activities program wide and identifies areas for improvement or that require correction. Provides recommendations and oversees implementation of recommendations, as needed. 9. Collaborates directly with Investigators and leadership to prepare and execute corrective and preventative action plans and assist with quality reviews to ensure implementation and adherence to stated plan. 10. Collaborates with the Quality Education Unit in the design and execution of Regulatory Specialist trainings and continuing education. 11. Collaborates with regulatory team and management to prepare for and facilitate in interim monitoring visits, internal audits and external audits/inspections for highly complex clinical research studies. 12. Monitors, interprets, applies and communicates new and revised federal and state regulations, and local/institutional policies and guidance. 13. Functions as a team lead; assesses workload accountability. 14. Assists with Regulatory Affairs Specialist study transfer activities for training, documentation of training. 15. Performs project oversight, promotes change management and manages workload challenges and delegation as requested. 16. Partners with the CTO Quality and Education team to onboard, train, and mentor junior regulatory affairs staff. 17. Performs other duties as assigned.
Required Education and Experience
Bachelor’s degree in life sciences or other health related discipline required and minimum of five (5) years’ experience in regulatory affairs support.
Required Skill/Ability 1:
Demonstrated ability to interpret and apply extensive knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Proven ability to interpret high acuity clinical trial protocols and manage several studies concurrently while balancing competing priorities/deadlines.
Required Skill/Ability 2:
Professionalism, maturity, good judgment, works with confidential and proprietary material and protected health information. Superior interpersonal, communication and listening skills. Ability to work with individuals across the organization and external stakeholders. Team leader; mentors, teaches, coaches, delegates. Provides guidance, instruction and critical feedback.
Required Skill/Ability 3:
Highly autonomous worker with extreme flexibility in work focus; able to switch among studies without adverse effects. Assignments are time intensive and highly complex. Decisions are guided by expertise, context, independent judgment and clear to obscure guidelines and policies and can impact the areas of which they are accountable.
Required Skill/Ability 4:
Ability to initiate planning, researching and management of high acuity clinical trials using superior understanding and expert knowledge of study start up activities and clinical research processes across the study lifespan. Works under minimal supervision. Understands when to inform others of developments or issues with a specific study.
Required Skill/Ability 5:
Proficiency in Microsoft Office Suite (Word, Excel, Outlook, etc.); Internet skills.
Preferred Education, Experience and Skills:
Advanced degree and certificate in related field. Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience in a Cancer Center setting. Two or more years of supervisory or mentoring experience in regulatory affairs.
Preferred Licenses or Certifications:
SOCRA/ACRP/RAPs (or equivalent) certification or ability to obtain within one year of employment.
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 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.