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Clinical Research Jobs in New Jersey

Lead Clinical Research Associate

Integrated Resources, Inc

Raritan, New Jersey

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Adjudication, Cardiovascular, Clinical Practices/Protocols, Clinical Research, Clinical Trial Management, Communication Skills, Corrective Action, Cross-Functional, Documentation, Federal Laws and Regulations, GCP (Good Clinical Practices), Information Technology & Information Systems, Interpersonal Skills, Leadership, Metrics, Microsoft Office, Performance Analysis, Performance Metrics, Presentation/Verbal Skills, Project Planning, Project Tracking, Project/Program Management, Recruiting Strategy, Rehabilitation Nursing, Time Management, Vendor/Supplier Selection, Writing Skills
LOCATION
Raritan, New Jersey
POSTED
Today
Lead Clinical Research AssociateIntegrated 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 DescriptionTitle: Lead Clinical Research AssociateLocation: Raritan, NJ 08869Responsibilities: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 FileQualificationsQualifications: 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

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