Clinical Research Associate I

This is a fully remote position, open to applicants in Minnesota.

📋 Description

• Assist in the management of one or more multi-center clinical research studies for the CIBMTR CRO Services team.

• Conduct comprehensive remote and on-site monitoring visits, including reviewing source documents and essential regulatory documents.

• Evaluate site performance to ensure adherence to clinical trial protocols, regulations, ICH GCP guidelines, and NMDP standard operating procedures.

• Identify and convey site findings; manage inquiries; create study and site status reports.

• Analyze trends, compose visit reports and letters, and ensure resolution of issues along with corrective and preventative actions.

• Supervise operational elements of clinical trial sites in collaboration with project teams.

• Aid in site activation, study initiation, achievement of enrollment targets, collection of essential documents, and maintenance of the electronic Trial Master File.

• Act as the primary contact for site management concerns and provide support to Investigators, Study Coordinators, and site personnel.

• Review study site data and reports to ensure prompt and accurate submission and compliance with protocols.

• Assist in user acceptance testing for clinical database management systems.

• Monitor studies and milestones; generate, assess, and distribute management reports.

• Create, maintain, and deliver clinical trial and project-specific training materials.

• Support protocol maintenance, tracking, communication, and problem-solving related to studies.

• Collaborate with both internal and external team members to ensure high-quality trial execution.

• Engage in project teams and share team responsibilities.

• Fulfill training requirements and enhance study and site management processes, tools, templates, and best practices.

⛳️ Requirements

• Bachelor's degree in a healthcare or science-related field; equivalent relevant experience and/or education may replace the degree requirement.

• At least two years of experience in conducting clinical research studies in line with ICH GCP guidelines and/or verifying clinical data from medical records.

• Familiarity with clinical research study processes, study design, and protocol management.

• Understanding of medical terminology and anatomy/physiology.

• Proficiency in computer applications including word processing, databases, email, and internet usage.

• Skills in training and conflict resolution.

• Strong time management and problem-solving capabilities.

• Exceptional oral and written communication skills.

• Capacity to handle multiple deadlines and priorities while maintaining quality and punctuality.

• Outstanding attention to detail.

• Ability to independently resolve straightforward issues and seek guidance for complex problems.

• Skill in analyzing trends, identifying problems, and escalating appropriately.

• Adaptability to change and proficiency in navigating clinical research processes and stakeholder interactions.

• Willingness and capability to travel 25–50% domestically and internationally, potentially up to 70%.

• Must embody NMDP values in a professional manner.

• ACRP or SOCRA certification is preferred but not mandatory.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance plans.

• Opportunities for professional development and training.

• Flexible work arrangements.

• Generous paid time off and holiday leave.