Clinical Research Associate, Multi TA

Job Description: • 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. Requirements: • 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, 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. Apply tot his job Apply To this Job