The Study Start Up (SSU) team provides successful end to end coordination of Study Start-Up planning and execution activities including, but not limited to, investigator assessment and identification, pre-study development, site qualification, and site activation. SSU is a pivotal role requiring collaboration with internal and external stakeholders, working closely with the clinical study team, other internal functional areas, and Sponsors to support the study start-up process.
What You’ll Be Doing:
Project Oversight & Support
Leads and manages regional SSU efforts and develop Start-Up plans for country and site activation on studies of moderate scope and complexity
Participates in Sponsor meetings with respect to study start-up, including endorsement of the SSU operational targets & mitigation of delivery risks, establishing client expectations for delivery, communication, reporting, and metrics with oversight from a higher level SSU Lead when necessary
Partners closely with both Functional Leads and SSU team members to proactively identify and resolve study start up related issues
Feasibility & Site Identification
Oversees country and site feasibility activities, ensuring timely collection and evaluation of site capabilities, Regulatory & IRB/IEC considerations, and study-specific requirements; reviews / interprets site feasibility data to identify risks or barriers to site selection and activation
Coordinates with internal teams to confirm site recommendations and ensure alignment with study strategy
Regulatory & IRB/IEC Submissions & Approvals
Drives the regional Regulatory and IRB/IEC submission and approval strategy and manages country-level Regulatory and IRB/IEC submission and approval timelines
Participates in and coordinates country-level Regulatory and IRB/IEC submission preparation and approval activities, ensuring compliance with regional requirements
Coordinates cross-functional input (Regulatory, Medical, Legal, Clinical Operations) to prepare complete and accurate Regulatory and IRB/IEC submission packages
Site Essential Documents (SED) & ICF
Coordinate Informed Consent Form (ICF) development, country adaptation, review, negotiation, and approval with senior SSU support as needed.
Manage Site Essential Document (SED) requirements, templates, collection, review, approval, and second-level quality checks.
Budget & Contracts
Drives site budgets and contract negotiations, gains approval from Sponsor and Rho Legal, and files completed documents
Collaborates with applicable departments, Client, and stakeholders for obtaining site budget and contract templates and negotiation tools/trackers
Provides updates to Sponsor and internal team regarding negotiation progress and anticipated timelines
Systems, Metrics & Handoffs
Ensures that relevant SSU systems are maintained and up to date to analyze study start up progress metrics against targets/timelines
Ensures accurate documentation and timely handoffs to sponsor and internal project team
Stakeholder Engagement & Communication
Serves as the point of contact for client matters related to study start-up
Partners with Clinical Team Leads, CRAs, and the client to develop a strategy and timing for the Site Initiation Visit (SIV) and Site Activation
May support business development with proposal and bid defense efforts, including representing Rho in proposal meetings
Mentoring, Coaching, Leadership & Training
Provides operational oversight, guidance, and constructive feedback to SSU Associates on assigned projects
Oversees work quality of SSU Associates, providing clear expectations, timely feedback, and performance coaching
Leads components of project team meetings, delegating tasks appropriately and ensuring clarity of responsibilities
Requirements
Bachelor’s Degree along with at least 4 years clinical research experience, with 3 years of clinical study start up experience; global study start up experience is preferred
Sound understanding of applicable international and…