Study Start-up Lead
Rho Inc
Summary
The Study Start Up (SSU) team provides successful end to end coordination of Study Start-Up planning and execution activities including 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.
Job description
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
- At least 4 years clinical research experience
- 3 years of clinical study start up experience
- Sound understanding of applicable international and local Regulatory and IRB/IEC requirements and guidelines (i.e., ICH; GCP, and/or EU; Directives)
- Good knowledge of Regulatory and IRB/IEC submission processes for assigned countries
- Strategic and creative risk management and contingency planning
- Strong written, verbal communication, and presentation skills with the ability to express complex ideas to study personnel, internal and Sponsor team members
- Strong organizational skills and ability to manage priorities across multiple studies and interpersonal skills
- Strategic, tactical, and critical thinking skills with a client-focused action-oriented approach to work
- Proficient computer and internet skills, including working knowledge of MS office applications, such as MS Outlook, Word and Excel
Benefits
- Medical, Vision & Dental
- HSA & FSA
- EAP
- Life & Disability Insurance
- 401(k)
- Paid Time Off
- Holidays
- Parental Leave
- Bereavement Leave
Company overview
Rho Inc is a full-service contract research organization (CRO) headquartered in Durham, North Carolina, founded in 1984. The company specializes in providing comprehensive clinical research services across the entire drug development lifecycle, from program strategy to clinical trials and regulatory submissions. Rho operates as a trusted partner to pharmaceutical, biotechnology, and medical device companies, offering expertise in therapeutic areas including neurology, psychiatry, respiratory, pain, and immunology. With approximately 500-1000 employees, Rho has established itself as a leader in the CRO industry, recognized for its collaborative approach and scientific rigor. The company's 'Cohesion Effect' philosophy emphasizes strong partnerships with sponsors, investigators, sites, and patients to advance clinical research and bring new treatments to market efficiently. Rho has been consistently recognized as one of the Best Places to Work by the Triangle Business Journal for 12 consecutive years.