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Senior Clinical Research Associate

5-7 years
Not Disclosed
10 July 29, 2025
Job Description
Job Type: Remote Education: Doctor of Medicine (MD or equivalent) Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Senior Clinical Research Associate

Location: Remote (USA)
Company: Catalyst Clinical Research
Work Mode: Remote
Experience Required: Minimum 5 years (including 3 years in oncology trials)


Job Summary

Catalyst Clinical Research, a global provider of oncology-focused clinical trial solutions, is hiring a Senior Clinical Research Associate (CRA) to support biological and pharmaceutical development programs. This remote role involves monitoring clinical trial sites across an assigned territory with up to 80% travel, ensuring compliance with ICH-GCP and PhRMA guidelines, and contributing to high-quality trial execution. Ideal for experienced oncology CRAs seeking a dynamic and flexible opportunity in a top-tier CRO.


Key Responsibilities

  • Travel up to 80% within an assigned territory to monitor clinical trials as per the monitoring plan.

  • Conduct site evaluations, study initiations, routine monitoring, close-outs, and FDA audit preparations.

  • Develop and manage clinical trial sites across the territory.

  • Communicate site status and resolve study-related issues with Catalyst personnel.

  • Support Investigator Meetings, data collection, and FDA submission preparations.

  • Work closely with the Study Manager, Project Manager, Sponsor, Vendors, Data Managers, and Medical Monitors.

  • Maintain compliance with all SOPs, ICH-GCP, PhRMA, and applicable regulatory standards.

  • Maintain a home office and manage work in a time and cost-effective manner.


Required Skills & Qualifications

  • Bachelor’s degree in a science or health-related discipline or equivalent industry experience (minimum 7 years).

  • At least 5 years of clinical research experience, including 3 years in oncology trials.

  • Direct site monitoring experience with a CRO or sponsor company.

  • In-depth understanding of clinical trial methodology and regulatory compliance (ICH-GCP, PhRMA).

  • Strong organizational, communication, and time management skills.

  • Proficient in standard computer applications and remote tools.

  • Must be authorized to work in the U.S. (no visa sponsorship).


Perks & Benefits

  • Fully remote work model

  • Opportunities to lead cutting-edge oncology clinical trials

  • Dynamic and supportive team culture

  • Travel opportunities within the U.S.

  • Work-life flexibility


About Catalyst Clinical Research

Catalyst Clinical Research is a leading oncology-focused CRO offering tailored solutions to global biopharmaceutical and biotechnology companies. Through its flexible service models, expert teams, and global reach, Catalyst helps bring innovative therapies to market.


Call-to-Action

Ready to take the lead in oncology clinical trials? Apply now to join Catalyst Clinical Research as a Senior Clinical Research Associate and be part of a team that drives innovation in clinical development.