Regulatory Activation Manager

New Haven, New Haven County
Aug 09, 2014

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.

STARS Requisition Number 26711BR
Department Cancer Ctr
University Job Title Manager 2
Posting Position Title Regulatory Activation Manager
Bargaining Unit None
Job Category Managerial & Professional
Type of Employment Full Time
Duration Type Regular
Salary Grade 24
Work Location Medical School Campus
Worksite Address 2 CSS
Work Week Standard (M-F equal number of hours per day)
Position Focus: As an integral participant of the leadership team for research administration, this individual will provide overall management, structure, and regulatory leadership for the development and implementation of all regulatory activation processes within the Yale Cancer Center Clinical Trials Regulatory Activation Office. This will include working to assure compliance with Federal regulations for conducting studies under IND/IDE and according to GCP, as well as ensuring the protection of rights, welfare and safety of study subjects. Additionally the individual will be responsible for making informed decisions regarding the impact of established and proposed regulations on regulatory compliance issues for the Clinical Trials Office, communicating these developments to the senior management team, regulatory compliance staff, Yale Cancer Center faculty and Clinical Trials Office staff and formulating strategies to address these environmental changes. In collaboration with members of the YCC Protocol Review Committee, Principal Investigators (PIs) and the CTO Leadership, this individual ensures the proper development, review and prioritization of all new protocols and all other related activities required for expeditious protocol activation. Develops process for hand off to protocol implementation team and ensures process is maintained.
Principal Responsibilities 1. Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University. 2. Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed. 3. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 4. Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments. 5. Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies. 6. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 7. Manages and coordinates training sessions for assigned departments when new policies or practices are adopted. 8. Ensures compliance with University and federal regulations as they apply to the assigned departments. 9. Identifies, plans, and develops administrative policies for the assigned departments. 10. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 11. Assesses and makes recommendations regarding staff development and staffing levels. 12. Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis. 13. Manages a staff of exempt and non-exempt employees. 14. May perform other duties as assigned.Required Education and Experience Minimum requirement of Bachelor's Degree in related field and three years of related experience or an equivalent combination of education and experience.
Required Skill/Ability 1: Proven ability to hire, orient, train and manage Regulatory activation staff. Ability to define orientation needs for new regulatory staff; training and competency requirements, and areas for ongoing continuing education.
Required Skill/Ability 2: Expert on regulatory affairs in areas of FDA-regulated clinical research, Investigational New Drug and Investigational Device submissions and management, audits, and NIH and NCI regulations and reporting requirements.
Required Skill/Ability 3: Proven ability to develop specific short- and long-term objectives for staff. Knowledge of how to develop reports and metrics to reflect regulatory affairs activity. Ability to monitor infrastructure and evaluate metrics and outcomes to determine success of plans.
Required Skill/Ability 4: Knowledge and ability to develop all standard operating procedures as they relate to the activation of clinical research studies, ensuring compliance with international, national and institutional practice standards and guidelines, regulatory requirements, applicable laws and IRB policies.
Required Skill/Ability 5: Proven leadership skills.
Preferred Education, Experience and Skills: Master's degree in health or research related discipline and two years of related work experience in a similar job family. Experience must indicate ability to work with minimal supervision in a team atmosphere and receptiveness to direction. Familiarity with oncology preferred.
Preferred Licenses or Certifications: Certification as a Clinical Research Associate or Clinical Research Professional ( ACRP or SOCRA preferred).
Weekend Hours Required? Occasional
Evening Hours Required? Occasional
Drug Screen No
Health Screening No
Background Check Requirements All External candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. Please visit for additional information on the background check requirements and process.
Posting Disclaimer The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
Yale University is an affirmative action/equal opportunity employer. Yale values diversity in its faculty, staff, and students and strongly encourages applications from women and members of underrepresented minority groups.