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 USA$55k - $65k /yrRemote

About the Job

Requirements

  • A bachelor's degree in a life science, nursing, or pharmacy field and at least 1 year of direct work experience managing essential documents within the CRO, pharmaceutical, or biotechnology industry.
  • Good knowledge of the clinical research process and understanding of regulatory and central/local ethics submission processes for assigned countries, with working knowledge of current ICH GCP guidelines and applicable regulations.
  • A desire or career goal to grow into a traveling Clinical Research Associate role.
  • Written, verbal, and presentation skills to communicate work outcomes.
  • Attention to detail and ability to maintain high scientific quality standards.
  • Honesty, integrity, accountability, and mutual trust in contributing to a collaborative culture.
  • Ability to evaluate situations objectively and develop practical solutions.
  • Ability to adapt to changing environments and manage risk through planning and learning from outcomes.

Responsibilities

  • Collect, track, and review investigational site records related to subject screening and enrollment.
  • Assist in developing study plans and status reports.
  • Collect, track, and review all site regulatory documents.
  • Assist with developing and reviewing Informed Consent Forms.
  • Interact with sites, clients, vendors, and internal study team members.
  • Maintain the clinical trials management system and other project tracking tools.
  • Track study supplies and coordinate shipments of supplies to sites as needed.
  • Manage the study Trial Master File and ensure periodic Trial Master File audits.
  • Coordinate work with Clinical Research Associates conducting on-site monitoring.
  • Perform on-site co-monitoring and remote monitoring activities.
  • Regularly review data entered by investigational site staff according to data review and monitoring guidelines.
  • Work with the Project Manager, traveling Clinical Research Associates, and Lead Clinical Research Associate to support clinical-trial monitoring activities and track, collect, and review critical documents.
  • Assist Clinical Research Associates with query resolution and data reviews to ensure studies comply with study protocols, standard operating procedures, ICH GCP guidelines, and federal regulations.
  • Manage data entered into the clinical trials management system and other project tracking tools.

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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