Lead Clinical Research Associate

Lead Clinical Research Associate

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Title: Lead Clinical Research Associate

Location: Raritan, NJ 08869

Responsibilities:

Lead Clinical Research Associate:

Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.

The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL).

Additional responsibilities include:

Implementation of enrollment and recruitment strategies

Assistance in vendors' selection processes

Development, execution, management and compliance assurance of the Monitoring Plan

Review and approve trip reports, track scheduling, report submission metrics, site deviations and action items

Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions.

Development of training materials and study tools for site and CRA use

Assistance in formation of the Adjudication Committee including oversight of documentation collection and filing into the Trial Master File

Qualifications

Qualifications: Lead Clinical Research Associate:

BS/BA, MS is desirable

5+ years of site management of which a minimum of 2 years field monitoring experience

Knowledge of applicable standards and regulations for clinical trial

Proven oral and written communication skills

Proven planning skills; ability to create and track detailed project plans

Proven interpersonal, leadership, organizational and effective time management skills

Microsoft Office proficiency

Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion

Experience in Cardiovascular Therapeutic area

IVD Stud Experience

Medidata RAVE system