Research Program Integrator

The Clinical Research Project Manager (Research Program Integrator - RPI) is responsible for managing research activities. This role involves leading cross-functional planning, tracking, status communication, and execution of research projects. The RPI oversees the entire lifecycle of research projects, from strategic planning through development, active management, and closure, ensuring all quality, content, schedule, and budget targets are met. A key part of the role will involve serving as clinical research coordinator for a large clinical trial.

Roles and Responsibilities

• Manages cross-functional wing-to-wing execution of research activities defined by research managers to meet strategic research needs, including investigator-initiated studies, internal human subjects research studies, external sponsored research studies, and other research-related activities.
• Develops study documents including study plans, protocols, informed consent documents, and budgets in consultation with Research Managers, business stakeholders, and external investigators.
• Develops, negotiates, and ensures signature of research contracts, in consultation with Legal counsel, Research Managers, business stakeholders, external investigators, and external research contracting departments.
• Manages requests for, and facilitates shipment and tracking of, research devices and other research support items.
• Coordinates or conducts study training and monitoring for sponsored research.
• Monitors study progress and any applicable adverse events or deviations reporting for sponsored research.
• Collects research deliverables, ensures they are complete in accordance with research contracts, coordinates review and approval by research managers, processes payments.
• Checks quality and maintains records of research activity in compliance with good documentation practices and documentation management systems and processes.
• Ensures that the research activities abide by all defined cross-functional standards, meets the intent and letter of QMS, SOPs, GCP, Phased Review Discipline, and all compliance and regulatory requirements of the applicable regions.
• Good interpersonal skills. Develops relationships with and supports external research partners and manages communication with external sites in a professional and productive manner.
• Basic understanding of key business drivers; uses this understanding to accomplish own work. Good understanding of how work of own team integrates with other teams and contributes to the area.
• Autonomy to make decisions within a defined framework. Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters.

Required Qualifications

• Bachelors degree from an accredited university or college in science, engineering, clinical, or equivalent area plus at least 2 years of experience project managing clinical and/or technical research studies in an academic or clinical setting, industry, or government agency.

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, communicate, and execute programs.
• Demonstrated understanding/experience with Good Clinical Practices, global and regional research regulations, research processes, New Product Introduction (NPI) cycle, and cross-functional interdependencies
• Demonstrated success in projects requiring accuracy with details, documentation, and communication between parties
• Experience in working with a global and virtual team with ongoing positive outcomes and impact