Instagram
youtube
Facebook

Clinical Trials Management Associate Ii

0-2 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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: Clinical Trials Management Associate II

Location: Foster City, California
Company: Integrated Resources, Inc.
Employment Type: Contract
Industry: Life Sciences / Clinical Research


Company Overview

Integrated Resources, Inc. (IRI) is a strategic workforce solutions provider founded in 1996. With decades of industry experience, IRI delivers top-tier talent and workforce management across healthcare, IT, and life sciences sectors.


Position Summary

The Clinical Trials Management Associate II will independently manage various aspects of clinical trial operations including site visits, protocol compliance, CRO/vendor coordination, and data oversight. The role requires strong knowledge of regulatory requirements, GCP, and excellent project management and communication skills.


Key Responsibilities

  • Conduct site evaluations, initiations, monitoring, and close-out visits with limited supervision.

  • Ensure site compliance with protocols and regulatory standards.

  • Support timeline management and CRO/vendor coordination.

  • Assist in drafting and reviewing study documents (protocols, ICFs, CRFs, monitoring plans).

  • Help resolve data discrepancies and contribute to safety and study reports.

  • Lead or participate in cross-functional meetings and conference calls.

  • May assist in training Clinical Research Associates (CRAs) and Clinical Project Assistants (CPAs).

  • Participate in departmental or interdepartmental strategic initiatives.

  • Travel required.


Qualifications & Skills

  • Prior experience fulfilling Clinical Research Associate responsibilities.

  • Working knowledge of FDA/EMEA regulations, ICH guidelines, and GCP.

  • Strong verbal and written communication, interpersonal, and presentation skills.

  • Proficiency in Microsoft Word, Excel, and PowerPoint.

  • Ability to manage multiple priorities and anticipate project obstacles.

  • Experience with CRO/vendor management and document preparation is preferred.


Contact Information

Recruiter: Harris Kaushik
Phone: (650)-399-0891
Company: Integrated Resources, Inc.
Email: [Use job post to apply or contact recruiter]