Note: The job is a remote job and is open to candidates in USA. ICON Strategic Solutions provides sponsor-dedicated clinical research services supported by global expertise. The Clinical Research Associate (Start-Up) will support multiple cross-therapeutic clinical trials by identifying, qualifying, and activating sites, coordinating start-up documentation, and ensuring compliance with regulatory and project requirements.
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
Skills
- Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
- Preferred location is Nashville, TN ; near a major airport. TN/KY near major hub acceptable
- 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
- 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
- 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
Company Overview