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ICON Strategic Solutions · 1 week ago

Clinical Study Associate

United States

Full-time

Remote

Entry Level

1+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization, seeking a Clinical Study Associate to join their team. The role involves supporting critical day-to-day clinical study activities, collaborating with various teams to ensure successful execution of clinical studies.

Responsibilities

Provide support for critical day to day clinical study activities, including regulatory inspection readiness, in accordance with established protocols, under the supervision of the CSA Manager

Collaborate with CSA colleagues, study teams and Clinical Research Organisations to support clinical study activities as defined by the operating model

Demonstrate proficiency in maintaining study team rosters, understanding the importance of TMF quality control for inspection readiness, and effectively monitoring site reports while addressing concerns with the Clinical Study Manager

Maintain an organized list of Standard Operating Procedures (SOPs)

Vendor budget/invoice tracking

Check patient enrollment, timelines and running metrics reports

Work with the Sponsor Clinical Study Associate on the Study Team Training matrix

Qualification

Veeva VaultClinical research experienceRegulatory compliance knowledgeTask managementCross-functional collaborationFluent business EnglishProblem solving skillsTeamwork skillsOrganizational skills

Required

Bachelor's degree in Life Sciences, Health Sciences, or a related field

1-2 years' experience in pharmaceutical industry, clinical research organization, or related role

Experience in Phase 2 and 3 Studies and global/international studies is advantageous

Experience working across multiple therapeutic areas (including oncology) is advantageous

Knowledge in global/regional regulatory and compliance requirements for clinical research

Demonstrated excellence in task management and cross-functional collaboration

Excellent communication skills

Excellent teamwork, organizational, interpersonal and problem solving skills

Fluent business English (oral and written)

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.