Study Start-Up Associate at Rho - CRO Career Growth

Rho Inc

United States

Remote

USD 55,000 - 65,000

Full time

2 days ago
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Benefits offered by this job

Medical coverage
Dental coverage
Vision coverage
HSA
FSA
EAP

Job summary

Rho Inc. is hiring a Study Start-Up Associate for a remotely based role in the United States.

This entry-level position requires a Bachelor’s degree and at least 1 year in clinical research, offering exposure to regulatory submissions, TMF management, and cross-functional coordination within CRO teams. The role emphasizes site activation, feasibility assessments, budget and contract support, and maintaining SSU trackers.

Qualifications

  • Bachelor's degree required with 1 year of clinical research experience.
  • Good knowledge of ICH GCP guidelines and regulations.
  • Experience with regulatory submissions and TMF documentation preferred.

Responsibilities

  • Coordinate start-up activities through site activation with high-quality, timely delivery.
  • Assist with site feasibility, site identification, and CDAs.
  • Support regulatory/IRB submissions and approvals at country and regional levels.
  • Maintain SSU trackers, databases, and TMF documentation.
  • Liaise on budget and contract processes with sites and sponsors.

Skills

ICH GCP knowledge
TMF management
Regulatory submissions
Budget negotiation support
Stakeholder management

Education

Bachelor's degree

Tools

Clinical trial systems

Job description

Study Start-Up Associate at Rho - CRO Career Growth — Remote

This Study Start-Up Associate role at Rho offers an excellent entry point into the clinical research/CRO industry. With just one year of experience required and a Bachelor's degree, it's well-suited for early-career professionals looking to build a foundation in clinical trial operations.

Compensation context: The $55,000–$65,000 range is competitive for an entry-level CRO associate in mid-tier US markets, though it may feel modest in high cost-of-living cities like Boston or San Francisco. Candidates in Research Triangle (NC) or similar biotech hubs would find this range reasonable.

  • ICH GCP compliance and regulatory submission workflows (IRB/IEC)
  • Trial Master File (TMF) management and documentation best practices
  • Contract and budget negotiation support—a highly transferable skill
  • Cross-functional stakeholder management across sponsors, sites, and legal teams
  • CRO-specific project tracking systems and metrics reporting

Career trajectory: SSU Associate → SSU Lead → Clinical Operations Manager is a well-defined path in CROs, and Rho's emphasis on internal stability suggests real promotion potential.

Green flags: Rho highlights financial and workforce stability—a meaningful signal in an industry prone to consolidation. The collaborative, science-forward culture and low turnover in the SSU team are strong positive indicators.

Watch for: The salary ceiling of $65,000 is modest; ensure you understand the promotion timeline and merit increase structure before accepting.

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. We're not your typical CRO, and we're not trying to be. Here, curiosity is encouraged, fresh approaches are welcome, and collaboration is at the heart of everything we do.

Whether you're a data wizard, analytical genius, project mastermind, or any other role, you'll fit right into the equation of the Rho Factor. Expect plenty of geeky jokes, eccentric personalities, spontaneous brainstorms, and a supportive community where people genuinely care about their work—and each other.

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.

As our next Study Start-Up Associate, you will 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 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.

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 the SSUL on required document collection, preparation, and execution of the Regulatory & IRB/IEC approach for submission and approval at specified regional levels, including country-level approval, and participates in local approval activities; provides administrative support during Regulatory and IRB/IEC submission and approval workflows (e.g., formatting, QC checks, document versioning, uploading documents to 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 the Site Essential Document (SED) package under the guidance of the SSU Lead.
  • Supports the adaptation of site-level Informed Consent Forms (ICFs), including review, QC checklist, negotiation, and approval with relevant internal and external parties.
  • 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 track 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.

Requirements

  • 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.

Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance, and 401(k). All employees are eligible for paid time off, holidays, parental leave, and bereavement leave.

  • medical
  • vision
  • dental
  • HSA
  • FSA
  • EAP
  • life & disability insurance
  • 401(k)
  • paid time off
  • holidays
  • parental leave
  • bereavement leave

Flexibility: We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation it reasonably expects to pay for a given role. Actual compensation is influenced by a wide array of factors including role responsibilities and location as well as candidate skill set and level of experience. The range of starting pay for this role is $55,000–$65,000 per year.

Is the Study Start-Up Associate role at Rho fully remote? Rho emphasizes work-life balance and flexibility, but the job posting does not explicitly designate this role as fully remote. It is listed for the United States, and candidates should confirm remote or hybrid expectations directly with the hiring team. What is the salary range for this role? The starting pay range for the Study Start-Up Associate at Rho is $55,000–$65,000 per year, with actual compensation influenced by factors such as location, experience, and role responsibilities. What experience is required to apply? Candidates need a Bachelor's Degree and at least 1 year of experience within a clinical research setting, preferably at a CRO, along with a working knowledge of ICH GCP guidelines. What benefits does Rho offer? Rho offers a comprehensive benefits package including medical, dental, vision, HSA, FSA, EAP, life and disability insurance, 401(k), paid time off, holidays, parental leave, and bereavement leave. What does the Study Start-Up Associate role involve day-to-day? The role involves coordinating site feasibility assessments, managing IRB/IEC regulatory submissions, handling site essential documents and informed consent forms, supporting contract and budget negotiations, and maintaining tracking systems for clinical trial sites from identification through activation.

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