YCCI Protocol Activation & Amendment Coordinator

YCCI Protocol Activation & Amendment Coordinator Yale University - 4.2 New Haven, CT Job Details Full-time $61,500 - $91,875 a year 17 hours ago Qualifications Research project management Confidential information handling Research ethical considerations Customer service Project management lifecycle Health information regulatory compliance Managing projects Research regulatory compliance Project stakeholder communication Full Job Description Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Overview The Protocol Activation & Amendment Coordinator (PAAC) is an integral member of the Protocol Activation and Lifecycle Management (PALM) team at Yale Center for Clinical Investigation, which processes and project-manages the activation for new research studies and amendments for ongoing studies. The PAAC role promotes an environment built around efficiency, collaboration, quality, compliance and study team satisfaction. Reporting to the Senior Clinical Trial Project Manager, the PAAC is highly skilled both technically and interpersonally - someone who can navigate data with complex logic while also communicating with all stakeholders clearly and effectively. The PAAC must be skilled in collaborative project management processes and providing operational support to a wide variety of stakeholders. Key day-to-day tasks include managing the PALM shared inbox, triaging urgent actions to the appropriate party, problem solving identified barriers, ensuring IT systems/data are accurate and complete (data integrity checks, document upload/data entry), and assisting with the day-to-day operations of the PALM team. This role collaborates and coordinates effectively with the other members of the PALM team, Principal Investigators and study teams, as well as other units/departments within the university (e.g., Clinical Operations, Office of Sponsored Projects (OSP), Human Research Protection Program (HRPP), Clinical Research Finance) and when needed, clinical trial sponsors/vendors or teams at other academic centers. The PAAC is responsible for assisting with the setup, build, activation, and ongoing support of all trial types including federally-funded, foundation, industry-sponsored, and investigator initiated human subject research. With a focus on administrative activities, this role requires effective written and verbal communication and attention to detail, as well as an ability to learn new technology quickly, stay organized, and leverage data to identify and resolve bottlenecks. Required Skills and Abilities 1. Strong technology/analytical and problem-solving skills. Capable of developing creative solutions to complex problems. 2. Strong organizational skills and attention to detail with the ability to multi-task, maintain confidentiality and manage a broad variety of duties and shifting priorities. 3. Proficient at working in team environments as well as self-directed independent projects. Ability to manage multiple projects concurrently while balancing priorities and deadlines. 4. Demonstrates regulatory compliance understanding. Ability to understand and communicate implications of federal regulations and university policies related to clinical research and data compliance. 5. Strong communication and collaboration skills. Demonstrates a high degree of customer service. Ability to communicate effectively and diplomatically in written and verbal forms with internal and external contacts, faculty, researchers and staff at all levels. Preferred Education, Experience, Skills, and Abilities 1. Bachelor's degree and/or a combination of 3 years work in a related research/IT/administrative role. 2. Knowledge of clinical trial processes, HIPAA regulations and IRB requirements. 3. Experience using technological systems (e.g., Clinical Trial Management Systems, Electronic Health Records, Excel, Salesforce) and leveraging data to identify insights, trends and areas for improvement. 4. Direct experience with OnCore, EPIC, Power BI, and Salesforce; project management experience. Principal Responsibilities 1. Manages processing, tracking, and filing of study documents and updates including adverse and serious adverse events, IND Safety Reports, Investigator Brochures, Package Inserts, and Instructions for Use. 2. Collaborates with Investigators, study teams, and Project Managers to gather, review, and maintain essential regulatory documents. 3. Collates aggregate study data into reports for external audiences including data and safety monitoring groups, regulatory authorities, and project funders. 4. Assists Project Managers in study oversight responsibilities and supports study management activities including drafting and revising study specific materials. 5. Manages study systems set up, access, and revisions, including Clinicaltrials.gov, CTMS (OnCore), Electronic Data Capture Systems, and regulatory document systems. 6. Assists in implementation of improvements and, solutions and assistance as needed under the supervision of senior team members. 7. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 8. Assists in the development and preparation of budgets. 9. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 10. Ensures compliance with University and federal regulations as they apply to the assigned departments. 11. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 12. May perform other duties as assigned. Required Education and Experience Bachelor's Degree in related field and two year of related experience or an equivalent combination of education and experience. Required License(s) or Certification(s) Required License(s) or Certification(s):

Physical Requirements Physical Requirements:

Job Posting Date 05/27/2026 Job Category Professional Bargaining Unit NON Compensation Grade Administration & Operations Compensation Grade Profile Supervisor; Senior Associate (22) Salary Range $61,500.00 - $91,875.00 Time Type Full time Duration Type Staff Work Model Remote Background Check Requirements All 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. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website. Health Requirements Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy. Posting Disclaimer Salary offers are determined by a candidate's qualifications, experience, skills, and education in relation to the position requirements, along with the role's grade profile and current internal and external market conditions. 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 position. Employees will be assigned specific job-related duties through their hiring department. The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual's sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran. Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA). Note Yale University is a tobacco-free campus.