Clinical Research Associate (Start Up) - Cross TA - Miami

Clinical Research Associate (Start Up) - Cross TA - Miami, FL reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the future of clinical development What will you be doing?

• Works on multiple trials reputed company the Cross Therapeutic areas - Start up focusÂ
• Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
• reputed company 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 reputed company process.
• Ensure that reputed company 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 reputed company) to reputed company timely site activation.
• Act as the main reputed company of contact for sites, study teams, and external stakeholders throughout the start-up process.
• Work closely with the country operations team to manage investigator reputed company, regulatory documents, and site-specific start-up activities.
• reputed company regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
• Monitor, report on, and analyze key performance indicators (KPIs) reputed company to site selection and start-up timelines.
• Proactively identify and address any issues that may delay study initiation or reputed company trial deliverables.
• Maintain precise documentation to ensure readiness for inspections.
• Support sites during the activation phase until they reputed company “Green Light†status for site opening.
• Facilitate coordination with site staff to ensure reputed company pre-study requirements, including reputed company, 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 Miami, FL ; near a major airport.Â
• Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
• Have a minimum of 1-3Â 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 reputed company of our study timelines
• Ability to operate and use various systems and databases (e.g. CTMS, reputed company, 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 reputed company status.

What reputed company can offer you: Our reputed company depends on the quality of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements
• A reputed company 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 reputed company.
• Global Employee Assistance Programme, reputed company, offering 24-hour reputed company 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.

Visit our careers site to read more about the benefits reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles. Are you a reputed company reputed company Employee? Please click here to apply Apply tot his job Apply To this Job