Apply on Employer Site

ICON Strategic Solutions · 3 weeks ago

Lead Clinical Research Associate- Ophthalmology

Texas, United States

Full-time

Hybrid

Lead/Staff

ICON plc is a world-leading healthcare intelligence and clinical research organization. The Lead Clinical Research Associate (CRA) will oversee and manage clinical trial sites, ensuring compliance with regulatory requirements and study protocols while driving site performance and providing mentorship to CRAs.

Pharmaceuticals

Hiring Manager

Christine Kuebler

Responsibilities

Leading site management activities, including site selection, initiation, monitoring, and close-out visits, to ensure compliance with study protocols and regulatory guidelines

Serving as the primary point of contact for clinical sites, addressing site queries, and resolving issues to maintain site engagement and performance

Ensuring the integrity of clinical data by conducting thorough source data verification, reviewing site records, and monitoring for protocol deviations

Mentoring and providing guidance to CRAs, contributing to their professional development and supporting the consistent application of best practices across studies

Collaborating with cross-functional teams, including clinical project managers, data managers, and biostatisticians, to ensure the successful execution of clinical trials

Qualification

Clinical trial managementICH-GCP guidelinesRegulatory requirementsLeadership skillsCommunication skillsProblem-solving skillsMentoring skillsOrganizational skills

Required

Bachelor's degree in life sciences, nursing, pharmacy, or a related field

Extensive experience as a Clinical Research Associate within the pharmaceutical, biotech, or CRO industry, with a proven track record of managing complex clinical trials

In-depth knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes

Strong leadership and mentoring skills, with the ability to manage and motivate CRAs and site staff effectively

Excellent communication, organizational, and problem-solving skills, with a proactive approach to managing site performance and resolving issues

Preferred

Advanced degree preferred

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.