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Rho

Study Start-Up Associate

Rho

. Participate in the study start-up process through site activation .

Posted 11/4/2026full-timeRemote • United StatesJuniorMid-Level💰 $55,000 - $65,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in clinical research processes, regulatory submissions, and site management while maintaining strong organizational skills and attention to detail. Capable of collaborating effectively with multidisciplinary teams and managing multiple priorities in a fast-paced environment.

Highest-signal resume keywords
Clinical Research ExperienceRegulatory Submission KnowledgeICH GCP Guidelines FamiliaritySite Management SkillsStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Research ProcessesRegulatory Submission ProcessesSite ActivationFeasibility AssessmentDocument ManagementQuality Control ChecksBudget TrackingContract NegotiationTMF DocumentationInformed Consent Form Management
Soft Skills
Attention to DetailOrganizational SkillsTime ManagementTeam CollaborationPositive Attitude
Tools & Technologies
SSU TrackersDatabasesRegulatory PlatformsIRB/IEC Platforms
Industry Keywords
CROIRBIECClinical TrialsMedical TerminologySite BudgetsStudy Start-UpFeasibility QuestionnairesSite Essential DocumentsClinical Operations

About the role

Key responsibilities & impact
  • Participate in the study start-up process through site activation
  • Provide timely and professional customer service to internal and external parties
  • Collaborate with Feasibility, CTL, SSUL, Rho Legal, Sponsors, site staff, and multidisciplinary project teams
  • Obtain site lists and ensure fully executed CDAs are established
  • Contribute to trial feasibility by distributing questionnaires and following up with site personnel
  • Maintain SSU trackers, databases, shared documentation, and relevant metrics
  • File site-level feasibility documentation in the TMF
  • Support regulatory and IRB/IEC document collection, preparation, execution, submissions, and approvals
  • Provide administrative support including formatting, quality control checks, document versioning, and uploading documents to regulatory and IRB/IEC platforms
  • Coordinate site-level regulatory and IRB/IEC submissions and approvals
  • Create, distribute, collect, review, and approve Site Essential Document packages under SSU Lead guidance
  • Support adaptation, review, quality control, negotiation, and approval of site-level Informed Consent Forms
  • Track, maintain, and file SED documentation in SSU databases, trackers, and TMF
  • Liaise with Rho Legal and sites to facilitate negotiation and execution of site budgets and contracts
  • Track budgets and contracts, update databases, file documents, and collect site-level information
  • Maintain systems to track site-level progress and support SSU progress metrics
  • Partner with the SSU Lead to determine and execute site-by-site handoffs to Clinical Operations

Requirements

What you’ll need
  • Bachelor’s Degree
  • 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

Comp & perks
  • Medical insurance
  • Vision insurance
  • Dental insurance
  • HSA
  • FSA
  • EAP
  • Life insurance
  • Disability insurance
  • 401(k)
  • Paid time off
  • Holidays
  • Parental leave
  • Bereavement leave
  • Work-life balance flexibility