[Hiring] Study Start-Up Associate @Rho Inc

Role Description

As our next Study Start-Up Associate, you will have the opportunity to work closely with the multidisciplinary project team across the life cycle of the project to ensure Study Start-Up is thoughtfully planned and delivered in a consistent, timely, and high quality manner. 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
• 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: Participates in the start-up process through site activation, providing excellent customer service to internal and external parties in a timely and professional manner.
• Feasibility & Site Identification:
  • Collaborates with the Feasibility team, CTL, SSUL, Rho Legal, Sponsor, and relevant site staff to obtain site lists and ensure fully executed CDAs are established.
  • Contributes to the trial feasibility process, specifically distributing questionnaires and following up with site personnel to ensure comprehensive responses are collected.
  • Maintains SSU trackers, databases, and shared documentation to track relevant metrics related to site identification and selection activities.
  • Ensures required site level feasibility documentation is filed in the TMF.
• Regulatory & IRB/IEC Submissions & Approvals:
  • Collaborates with and supports SSUL on the required document collection, preparation and execution of the Regulatory & IRB/IEC approach for submission and approval at specified regional levels.
  • Participates in local approval activities; provides administrative support during the Regulatory and IRB/IEC submission and approval workflows (e.g., formatting, QC checks, document versioning, uploading documents to Regulatory and IRB/IEC platforms).
  • Ensures Regulatory and IRB/IEC documents are filed and maintained accurately in SSU trackers, TMF, and databases.
  • Coordinates with sites to ensure site level Regulatory and IRB/IEC submissions and approvals are obtained.
• Site Essential Documents (SED) & ICF:
  • Supports and may lead the creation, distribution, collection, review and approval of Site Essential Document (SED) package under the guidance of the SSU Lead.
  • Supports the adaptation of site level Informed Consent Forms (ICFs), including the review, QC checklist, negotiation and approval with relevant internal and external parties with support and oversight from the SSU Lead.
  • Tracks, maintains, and files SED documentation in SSU databases, trackers, and TMF.
• Budget & Contracts:
  • Liaises with Rho Legal and sites to facilitate and support the negotiation and execution of site budgets and contracts.
  • Provides administrative support, maintains timely tracking, database updates, filing, and handling of budget and contract progress and documents.
  • Assists with collecting required site-level information needed for initial budget and contract preparation.
• Systems, Metrics & Handoffs:
  • Ensures relevant systems are maintained and up to date to keep track of site-level progress, enabling the SSUL to analyze SSU progress metrics against study-level targets and timelines.
• Stakeholder Engagement & Communication:
  • Partners with the SSU Lead to identify and execute the suitable timing of handoff to Clinical Operations on a site-by-site basis.

Qualifications

• Bachelor’s Degree along with at least 1 year of experience within the clinical research setting, preferably within a CRO.
• Good knowledge of general clinical research processes and medical terminology.
• Basic understanding of Regulatory and IRB/IEC submission processes for assigned countries.
• Working knowledge of current ICH GCP guidelines and applicable regulations.
• Good written and verbal communication skills.
• Takes initiative to complete project responsibilities, seeking guidance as needed.
• Good organizational and time management skills, able to meet deadlines; strong attention to detail.
• Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
• Ability to manage multiple competing priorities within various clinical trials and work as a strong team player.

Benefits

• Comprehensive benefits package including medical, vision, dental, HSA, FSA, EAP, life & disability insurance, and 401(k).
• Paid time off, holidays, parental leave, and bereavement leave.
• Encouragement of work-life balance.

Company Description

Join us in redefining what it means to work for a CRO. When you work at Rho, it’s more than just a job—you become part of the Rho Factor. We’re a proud bunch of science nerds who love tackling big challenges together. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.