Clinical Research Associate II

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

📋 Description

• Conduct independent full-scope remote and on-site monitoring visits, which encompass source document verification, review of key regulatory documents, and assessment of site performance.

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

• Identify and relay site findings to site study personnel and the study team.

• Manage queries and produce study and site status reports.

• Analyze trends in identified issues and compile visit reports and correspondence.

• Ensure the documentation and resolution of identified issues while implementing corrective and preventive actions.

• Act as the Lead CRA for studies with multiple assigned CRAs as necessary, which includes monitoring study metrics, ensuring compliance with the clinical monitoring plan, and escalating study risks.

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

• Assist with site activation and ensure that study start-up and enrollment objectives are achieved.

• Gather and review essential investigational site documents and maintain the electronic Trial Master File.

• Serve as the primary point of contact for site management issues and escalate them to the clinical project manager as needed.

• Provide support to Investigators, Study Coordinators, and other personnel regarding study workflow, challenges, and conduct.

• Lead and mentor others in reviewing study-site data and reports to ensure timely, accurate submission and compliance with protocols.

• Assist and train CRAs in user acceptance testing of clinical database management systems.

• Conduct study tracking and generate, review, and distribute management reports.

• Develop, maintain, and deliver training materials specific to clinical trials and projects.

• Lead problem-solving activities related to studies both internally and at trial sites.

• Assist with protocol maintenance, tracking, and communications.

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

• Participate in shared team responsibilities and contribute to NMDP, CIBMTR, or CIBMTR CRO Services project teams as required.

• Complete and uphold all training obligations.

• Develop, maintain, and enhance study and site management processes, guidelines, tools, templates, best practices, and their implementation.

• Participate in the training of junior CRAs.

• May provide expert input on study protocols, case report forms, and clinical monitoring plans.

⛳️ Requirements

• Advanced knowledge of clinical research study processes, study design, and/or protocol management.

• Strong understanding of clinical trial monitoring procedures and clinical data reporting processes.

• Familiarity with medical terminology and anatomy/physiology.

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

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

• Excellent time management and problem-solving skills.

• Outstanding oral and written communication abilities.

• Capacity to manage multiple deadlines and priorities independently while ensuring quality and timeliness.

• Keen attention to detail.

• Ability to independently solve problems and make decisions in complex situations with minimal guidance.

• Proficient in analyzing trends, identifying issues, and escalating them as necessary.

• Adaptability to change and the ability to navigate clinical research processes and stakeholders.

• Must embody NMDP values in a professional manner.

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

• Bachelor’s degree in a healthcare/science-related field or equivalent related experience and/or education evaluated accordingly.

• At least three years of experience in conducting clinical research studies.

• A minimum of one year of direct experience in monitoring clinical research studies or managing sites and protocols from a sponsor or CRO viewpoint.

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

• Preferred: direct experience working at research sites on clinical studies.

• Preferred: ACRP or SOCRA certification.

🏝️ Benefits

• Medical benefits

• Dental benefits

• Vision benefits

• Life benefits

• Disability benefits

• Accident/critical illness/hospital benefits

• Well-being benefits

• Legal benefits

• Identity theft benefits

• Pet benefits

• Retirement plan

• Paid time off and holidays

• Leave plans

• Incentive plans