Title:  Clinical Research Manager
Location:  New Haven, CT
Duration:  Direct Hire
Schedule:  Mon-Fri, Full time
Target Start Date:  ASAP

Responsibilities:
Responsible for leading, managing, and advising designated research staff/program teams as well as acting as a study coordinator within a Section of Digestive Diseases clinical trials program (50-50 spilt)

• Provides oversight by monitoring the conduct of research within the section and reports to section leadership on regulatory compliance with University, State, and Federal regulations and requirements
• Monitors and reports to section leadership on fulfillment of financial and contractual requirements for sponsored research including federal and non-federal research projects
• Assists as needed in the development and startup of new research protocols and programs
• Develops, coordinates, and promulgates section standard operating procedures (SOPs) employing regulatory compliance and best practices
• Develops, maintains, analyzes, and distributes centralized section data characterizing and describing section research activity and statuses
• Identifies, addresses, and resolves specific problematic events and issues as may be found during monitoring duties and as may be directed by leadership
• Provides expert regulatory and best practices guidance to section leadership, researchers, study coordinators, and other section personnel as may be needed; mentors and develops staff
• Conducts periodic reviews of the section’s research portfolio and evaluates the research infrastructure to ensure best use of resources and clinical trial accrual, while providing solutions to leadership
• Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve delays and issues as may be required
• Directly supervise study coordinators
• Organizes regular meetings with section clinical research leadership team
• Serves as a liaison to a variety sponsors from the for-profit, non-profit and governmental sectors to assure compliance with the latest sponsor proposal policies and procedures
• Reviews and assures transmittal of proposals to potential sponsor(s) after verifying compliance with submission requirements, policy and procedures, and applicable regulations
• Coordinates on large institutional proposals and proposals including multi-disciplinary submissions to assure compliance with submission requirements
• Reviews incoming Notices of Award and other sponsor award documents; recommends acceptance of awards based on knowledge of policies and governmental requirements
• Administers a large and varied portfolio of agreements including grants, cooperative agreements, contracts, subcontracts, material transfer agreements and confidential disclosure agreements
• Implements, and communicates information on all aspects of sponsored projects administration as it is developed or revised
• Obtains, evaluates and communicates information on electronic research processes and procedures of sponsors as it is implemented
• Responds to inquiries and provides direct assistance to research faculty campus
• Creates procedures to maintain and track research compliance in areas such as human subjects and animal care and use
• Plans and executes strategic research initiatives and business plans to increase sponsored research support

• Bachelor’s Degree in public administration, business management, or related field
• Five years related work experience or equivalent combination of education and experience
• Five years’ demonstrated ability in managing research studies
• Demonstrated expertise and in-depth knowledge of Federal Human Subjects Protection regulations, guidance’s and policies ICH/Good Clinical Practice (GCP)
• Full knowledge of Microsoft Office and Outlook
• Ability to work independently with a minimum of direction
• At least two years of employee management/supervisor skills
• Experience with managing sponsored and non-sponsored (investigator-initiated) research protocols and IND or IDE specific regulations

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.