Clinical Research Associate II

This is a fully remote position, open to applicants in Arizona, +2 more states.

📋 Description

• Provide oversight and management support for BDPI clinical studies at various sites.

• Ensure that all assigned clinical studies adhere to quality standards, compliance, scientific integrity, and ethical considerations.

• Conduct monitoring activities at clinical sites, either on-site or remotely.

• Assess sites for qualification or activation and review informed consent forms and participant data.

• Generate and address data queries while escalating issues related to study non-compliance.

• Confirm corrective actions, maintain investigational product accountability, and secure necessary regulatory approvals.

• Review essential study documentation and conduct training sessions and presentations related to the study.

• Ensure prompt reporting of reportable events and maintain sufficient study supplies.

• Act as a resource for BD stakeholders and investigators regarding products, procedures, and clinical study protocols.

• Cultivate and sustain relationships as the primary contact for sites.

• Facilitate communication between clinical sites, BD stakeholders, and cross-functional study teams.

• Develop and oversee study-specific tracking reports.

• Conduct audits of the Trial Master File and address or escalate any quality issues identified.

• Assist in the management of the Clinical Trial Management System.

• Prepare and finalize essential documents for clinical study activation, monitoring, training, and accountability.

• Contribute insights on clinical project management, data management, statistics, safety, and supplier documentation.

• Identify opportunities for enhancing clinical study performance and provide feedback across functions.

• Communicate product complaints and other events that may impact the study to BD stakeholders.

• Participate in or lead meetings with study teams, Clinical Research Associates, and vendors.

• Support the clinical project management team with administrative tasks.

• Identify challenges and develop mitigation strategies in collaboration with Clinical Project Management and leadership.

• Assist with internal or external audits and inspections.

• Promote continuous improvement and best practices within the team.

• Mentor Site Management & Monitoring staff and conduct evaluations or co-monitoring visits.

⛳️ Requirements

• Bachelor's Degree (BS/BA) in life sciences or an equivalent combination of education and experience (MA/MS preferred).

• Over 3 years of experience in clinical research, specifically in medical devices, pharmaceuticals, and/or biotechnology.

• At least 2 years of experience in site management & monitoring or in managing clinical projects.

• Familiarity with domestic and international clinical research regulations and guidelines.

• Understanding of Good Clinical Practice (ICH GCP/ISO14155) and current industry standards.

• Proficiency in Microsoft Suite applications, including Outlook, Word, Excel, PowerPoint, OneNote, To-Do, and SharePoint.

• Extensive knowledge of clinical study processes and systems, such as eTMF, CTMS, and CDMS.

• Excellent interpersonal, communication, and presentation skills.

• Strong organizational skills with attention to detail, critical thinking, and analytical capabilities.

• Ability to manage and delegate multiple tasks while prioritizing projects effectively.

• Willingness to travel up to 60% or more during peak periods.

• This role may be offered in any location within the United States.

• Must reside within a 45-minute commute of an international airport.

🏝️ Benefits

• Flexible remote or field-based work arrangements.

• Opportunities for professional growth and development.

• A collaborative culture that emphasizes face-to-face learning and teamwork.

• COVID-19 workplace accommodations available in accordance with applicable laws.