Clinical Specialist - Integrated Resources, Inc ( IRI ) : Job Details

Clinical Monitoring Lead

Location: Cambridge, MA-Hybrid

Duration: 6 months

About the Role

A Clinical Monitoring Lead is responsible for coordinating clinical activities and site management for international registrational studies.

Responsibilities

• Minimum: CRA (Clinical Research Associate) graduate
• Life science or medical graduate or other relevant qualifications
• Experience in pharmaceutical drug development
• Lead CRA experience
• Field CRA monitor experience
• Knowledge of Good Clinical Practice (GCP), ICH regulations
• Preparing clinical study documentation
• Managing relationships with Contract Research Organizations (CROs)
• Global studies experience
• Therapeutic area experience (Neuroscience, Oncology, radiopharmaceutical compound)

Qualifications

Education: CRA graduate, life science or medical graduate, or relevant qualifications

Required Skills

• Ability to work in a regulated environment within a quality management system (QMS)
• Advanced knowledge of software applications
• Organizational and prioritization skills
• Teamwork and multi-disciplinary environment skills
• Basic Financial Knowledge
• Knowledge of Pharmaceutical Industry R&D
• Continuous drive for improvement
• Strong organizational and interpersonal skills
• Verbal and written communication skills
• Professional awareness and integrity
• Pragmatic/hands-on approach
• Ability to work within a team and support others
• Proactive approach
• Flexibility