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ICON Strategic Solutions · 2 days ago

Clinical Research Associate (Start Up) Multi TA - Texas

United States

Full-time

Remote

Entry, Mid Level

2+ years exp

ICON plc is a world-leading healthcare intelligence and clinical research organization. They are seeking a Clinical Research Associate to work on multiple trials with a focus on start-up activities, collaborating with country operations teams and site personnel to ensure timely site activation and adherence to regulatory standards.

Responsibilities

Works on multiple trials within the Cross Therapeutic areas - Start up focus

Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements

Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies

Build strong relationships with site personnel to facilitate a smooth onboarding process

Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs)

Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation

Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process

Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities

Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones

Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines

Proactively identify and address any issues that may delay study initiation or affect trial deliverables

Maintain precise documentation to ensure readiness for inspections

Support sites during the activation phase until they achieve “Green Light” status for site opening

Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met

Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards

Qualification

Clinical trial monitoringClinical PracticeRegulatory complianceAnalytical monitoringPatient recruitment strategiesTherapeutic areasCTMSEDC systemsCommunication skillsTeam collaborationSelf-starter

Required

Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences

Must be located in Texas, near a major airport

Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials

Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials

Knowledge of several therapeutic areas

Analytical/risk-based monitoring experience is an asset

Ability to actively drive patient recruitment strategies at assigned sites

Ability to partner closely with investigator and site staff to meet all of our study timelines

Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting)

Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently

Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status

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.