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
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