Lead Clinical Research Associate

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

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

Kind Regards,

Sabanaaz Shaikh

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

• Gold Seal JCAHO Certified ™ for Health Care Staffing
• “INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)