Icon·13 days ago
13 days ago
Clinical Research Associate - Start up - Cross TA
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What you'll do
- 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.
What they're looking for
- Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
- Must be located in the West region; 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
- Study start up experience as a CRA
- 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.
Nice to have
- Analytical/risk-based monitoring experience is an asset
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Clinical Research Associate (Start up) - Cross Therapeutic Area - West Region
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
What will you be doing?
- 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.
What do you need to have?
- Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
- Must be located in the West region; 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
- Study start up experience as a CRA
- 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.
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Salary Range
$91,336.00-$114,170.00Are you a current ICON Employee? Please click here to apply
Company
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Washington, United States of America
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