YCCI Protocol Activation & Amendment Coordinator

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.