Research Development Analyst

Corewell Health • Grand Rapids, MI

4d • Onsite

About The Position

Under direct supervision of a manager, oversees a portfolio of research projects in development. Responsible for all aspects of the project through to activation, and business assurance requirements. Responsible for coordinating with the principal investigator, study team, research administration, clinical services and external partners to prepare, evaluate and implement research studies. To effectively coordinate the activities of the team and project, competency and familiarity are necessary with research methods, project management, and the roles and functions of teams throughout the system. Essential Functions Serves as project manager focused on start-up activities for a variety of research studies with various levels of regulatory, clinical, and operational complexity. Supports the Principal Investigator and research team members and is accountable to external sponsors for communications and updates related to study progress. Evaluates and prepares research studies for implementation. This includes leading activities such as the site selection process, review of sponsor provided study documentation, completing tools to support budget negotiation, and partners with clinical and nonclinical teams to support decision making. Leads and supports the service line and departmental vetting processes by providing summary analysis of the operational feasibility of the study. Prepares Internal Review Board application documentation which includes development of consent forms, communication with Sponsor on development updates and timelines, facilitates and attends meetings, and communicates to internal teams throughout the life cycle of development. Communicates, collaborates, networks, and acts as a consultant to the study sponsor and contract research organization, research study centers, academic institutions, investigators, physician offices, ancillary departments, and the multidisciplinary team. Partners with sponsor and study team to ensure post activation essential documentation maintenance requirements are met in accordance with federal laws, rules and regulations and local policies and procedures to follow to ensure compliance. Provides ongoing regulatory maintenance in departmental systems and in coordination with sponsor, and consulting on documentation changes. Tracks metrics and milestones related to project development using research enterprise systems and tools to ensure timely delivery and utilization of project management methodology.

Requirements

• Bachelor’s degree in health or science related, or equivalent
• 2 year of relevant experience in clinical research and project management
• Collaboration Institute Training Initiative certification required within 90 days of employment
• Good Clinical Practice certification required within 90 days of employment

Responsibilities

• Serves as project manager focused on start-up activities for a variety of research studies with various levels of regulatory, clinical, and operational complexity.
• Supports the Principal Investigator and research team members and is accountable to external sponsors for communications and updates related to study progress.
• Evaluates and prepares research studies for implementation.
• Leads and supports the service line and departmental vetting processes by providing summary analysis of the operational feasibility of the study.
• Prepares Internal Review Board application documentation which includes development of consent forms, communication with Sponsor on development updates and timelines, facilitates and attends meetings, and communicates to internal teams throughout the life cycle of development.
• Communicates, collaborates, networks, and acts as a consultant to the study sponsor and contract research organization, research study centers, academic institutions, investigators, physician offices, ancillary departments, and the multidisciplinary team.
• Partners with sponsor and study team to ensure post activation essential documentation maintenance requirements are met in accordance with federal laws, rules and regulations and local policies and procedures to follow to ensure compliance.
• Provides ongoing regulatory maintenance in departmental systems and in coordination with sponsor, and consulting on documentation changes.
• Tracks metrics and milestones related to project development using research enterprise systems and tools to ensure timely delivery and utilization of project management methodology.

Benefits

• Comprehensive benefits package to meet your financial, health, and work/life balance goals.
• Learn more here.
• On-demand pay program powered by Payactiv
• Discounts directory with deals on the things that matter to you, like restaurants, phone plans, spas, and more!
• Optional identity theft protection, home and auto insurance, pet insurance
• Traditional and Roth retirement options with service contribution and match savings
• Eligibility for benefits is determined by employment type and status

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees