R

Rho

Comprehensive CRO for regulatory drug approvals

In-House Clinical Research Associate

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in PolandNo salary listedRemote

About the Job

Requirements

  • A bachelor's degree in a life science, nursing, or pharmacy field and at least 1 year of direct experience managing essential documents within the CRO, pharmaceutical, or biotechnology industry.
  • Good knowledge of clinical research processes and understanding of regulatory and central/local ethics submission processes for assigned countries.
  • Working knowledge of current ICH GCP guidelines and applicable regulations.
  • A desire or career goal of growing into a traveling Clinical Research Associate role.
  • Fluency in both the local language and English.
  • Written, verbal, and presentation skills to communicate work and organizational successes.
  • Attention to detail, understanding of scientific quality standards, and care for outcomes.
  • Honesty, integrity, accountability, loyalty, and mutual trust in contributing to a collaborative culture.
  • Ability to evaluate situations objectively and develop practical solutions.
  • Ability to adapt quickly to changing circumstances.

Responsibilities

  • Collect, track, and review investigational site records relating to subject screening and enrollment.
  • Assist in developing study plans and status reports.
  • Collect, track, and review site regulatory documents.
  • Assist with development and review of Informed Consent Forms.
  • Interact with sites, clients, vendors, and internal study team members.
  • Maintain the clinical trials management system (CTMS) and other project tracking tools.
  • Track study supplies and coordinate shipments to sites as needed.
  • Manage the study Trial Master File (TMF) and ensure periodic TMF audits.
  • Coordinate work with CRAs monitoring on-site.
  • Perform on-site co-monitoring and remote monitoring activities.
  • Review data entered by investigational site staff according to data review and monitoring guidelines.
  • Work with the Project Manager, traveling CRAs, and Lead CRA to support clinical trial monitoring activities and track, collect, and review critical documents.
  • Manage data in the CTMS and other project tracking tools, and assist CRAs with query resolution and data reviews to support compliance with study protocols, Rho SOPs, ICH/GCP guidelines, and federal regulations.

About the Company

Rho

Comprehensive CRO for regulatory drug approvals

Rho is a contract research organization that provides end-to-end services for developing and gaining regulatory approval for drugs, biologics, and medical devices. It supports planning and executing clinical development, regulatory strategy, and marketing submissions, guiding projects from program strategy through NDAs, BLAs, and MAAs. An integrated team handles decentralized clinical trials and has infectious-disease programs, combining trial design, data management, and regulatory insight to move products toward approval. Its goal is to help clients bring products to market efficiently by navigating regulatory requirements and streamlining development and submission processes.

Company size
501-1,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Durham, NC
Founded
1984

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