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Lead Clinical Research Associate

5+ years
Not Disclosed
10 May 2, 2025
Job Description
Job Type: Full Time 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:

Lead Clinical Research Associate


Company:

Integrated Resources, Inc.


Location:

Raritan, NJ 08869 (On-site)


Job Type:

Full-time


About the Company:

Integrated Resources, Inc. (IRI) is a top-tier staffing firm established in 1996, providing high-quality professionals across four specialized domains:

  • Information Technology (IT)

  • Clinical Research

  • Rehabilitation Therapy

  • Nursing

IRI is known for delivering service with integrity and holds the Gold Seal JCAHO Certification. It is an 8-time honoree on the INC 5000 list of fastest-growing privately held companies.


Job Description / Responsibilities:

Under the supervision of the Clinical Project Lead (CPL), the Lead Clinical Research Associate (LCRA) is responsible for:

  • Overseeing performance of field monitors and site activities per Monitoring Plan and Protocol

  • Acting as the primary liaison between Field-Based CRAs and CPL

  • Supporting recruitment and enrollment strategies

  • Assisting in vendor selection processes

  • Developing, executing, and ensuring compliance with the Monitoring Plan

  • Reviewing and approving trip reports

  • Tracking visit scheduling, site deviations, report submissions, and action items

  • Monitoring site and CRA performance metrics

  • Leading issue escalation and corrective action plans

  • Creating training materials and study tools for site and CRA use

  • Assisting with the formation of the Adjudication Committee and TMF documentation oversight


Key Skills & Knowledge:

  • In-depth understanding of GCP, ICH guidelines, and clinical trial regulations

  • Strong planning and project tracking capabilities

  • Effective oral and written communication skills

  • Leadership and interpersonal skills

  • Familiarity with monitoring visit coordination and oversight


Minimum Qualifications:

  • BS/BA required; MS preferred

  • Minimum 5+ years of site management experience, including 2+ years of field monitoring

  • Experience with Medidata RAVE

  • Strong Microsoft Office skills

  • Ability to work independently and cross-functionally

  • Proven experience in issue identification and escalation


Preferred Experience:

  • Cardiovascular therapeutic area expertise

  • Experience with IVD studies


Recruiter Contact:

Sabanaaz Shaikh
Clinical Recruiter
Integrated Resources, Inc.
Website:
www.irionline.com