Senior Clinical Research Associate

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

📋 Description

• Conduct comprehensive remote and on-site monitoring visits independently, which include source document verification and assessment of vital regulatory documents.

• Ensure adherence to clinical trial protocols, regulations, ICH GCP guidelines, and NMDP standard operating procedures.

• Identify, manage, communicate, document, and resolve findings and corrective/preventive actions at the site.

• Manage queries and produce status reports for studies and sites.

• Analyze trends in issues and prepare visit reports and correspondence.

• Act as Lead CRA by developing and monitoring study metrics, ensuring compliance with the monitoring plan, and addressing study risks.

• Supervise clinical trial site operations, including site activation, study initiation, enrollment, essential document management, and maintenance of the electronic Trial Master File.

• Serve as the primary contact for site management concerns while supporting Investigators, Study Coordinators, and site personnel.

• Provide training to site staff on data reporting, study workflows, protocol adherence, and regulatory compliance.

• Lead centralized monitoring efforts, review site data and reports, and establish study-specific centralized data review processes.

• Monitor studies through CTMS and other systems, tracking start-up, milestones, and closeout activities.

• Create, maintain, and present training materials specific to clinical trials and projects.

• Assist with the maintenance of protocols and communications; contribute to the development of protocols, case report forms, and clinical monitoring plans.

• Author and review guidelines for the completion of study-specific CRFs.

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

• Mentor and provide training to junior CRAs and may conduct quality or performance assessment visits.

• Develop and continuously enhance study and site management processes, tools, templates, guidelines, and best practices.

• Complete mandatory training and undertake other assigned responsibilities.

⛳️ Requirements

• In-depth understanding of clinical research study processes, study design, and/or protocol management.

• Extensive knowledge of clinical trial monitoring procedures and clinical data reporting processes.

• Strong grasp of medical terminology and anatomy/physiology.

• Proficient in computer applications, including word processing, databases, email, and internet tools.

• Advanced skills in project management, training, and conflict resolution.

• Excellent time management and problem-solving capabilities.

• Proven leadership skills with a focus on collaboration and team motivation.

• Ability to independently manage multiple deadlines and priorities while ensuring quality and promptness.

• Exceptional attention to detail.

• Competence in independent problem-solving and decision-making in complicated scenarios.

• Ability to analyze trends, identify problems, and escalate them when necessary.

• Capacity to adapt to changes and lead clinical research processes and personnel.

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

• Capability to mentor junior team members.

• Bachelor’s degree in a healthcare/science-related field, or equivalent experience and/or education assessed on a case-by-case basis.

• Minimum of five years of experience in conducting clinical research studies.

• At least three years of direct involvement in monitoring complex clinical research studies.

• Must professionally embody NMDP values.

• Preferred: Advanced knowledge of cellular therapies, related diseases, disease assessments, and treatment complications.

• Preferred: Direct experience with clinical studies at research sites.

• Preferred: ACRP or SOCRA certification.

• Preferred: Advanced degree in a healthcare/science-related discipline.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability benefits.

• Coverage for accident, critical illness/hospital, well-being, legal, identity theft, and pet benefits.

• Retirement savings benefits.

• Paid time off and holiday leave.

• Various leave plans.

• Incentive programs for eligible employees.