Clinical Research Associate II

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❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

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NMDP

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1987

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

NMDP is a nonprofit organization (formerly Be The Match) that operates the national blood stem cell donor registry and coordinates cell therapy to treat blood cancers and other blood disorders. It recruits and registers donors, matches donors to patients, facilitates transplants, provides patient support and financial assistance, conducts and funds clinical research and trials, and leads advocacy and fundraising to expand access to life‑saving cell therapies.

📋 Description

• Independently perform full-scope remote and on-site monitoring visits, including source document verification, review of essential regulatory documents, and site performance assessment • Ensure compliance with clinical trial protocols, regulations, ICH GCP guidelines, and NMDP standard operating procedures • Identify and communicate site findings with site study personnel and the study team • Perform query management and generate study and site status reports • Analyze trends in identified issues and author visit reports and letters • Ensure documentation and resolution of identified issues and implementation of corrective and preventive action • Serve as Lead CRA on studies with multiple assigned CRAs when needed, including monitoring study metrics, overseeing clinical monitoring plan compliance, and escalating study risk • Oversee and manage operational aspects of clinical trial sites with project teams • Assist with site activation and ensure study start-up and enrollment goals are met • Collect and review essential investigational-site documents and maintain the electronic Trial Master File • Serve as primary liaison for site management issues and escalate to the clinical project manager as required • Support Investigators, Study Coordinators, and other staff regarding study workflow, obstacles, and study conduct • Lead and train others in reviewing study-site data and reports for timely, accurate submission and protocol compliance • Assist and train CRAs in user acceptance testing of clinical database management systems • Perform study tracking and generate, review, and distribute management reports • Develop, maintain, and present clinical trial and project-specific training materials • Lead study-related problem-solving activities internally and at trial sites • Assist in protocol maintenance, tracking, and communications • Work with internal and external team members to deliver high-quality trial execution • Participate in shared team responsibilities and NMDP, CIBMTR, or CIBMTR CRO Services project teams as needed • Complete and maintain all training requirements • Develop, maintain, and improve study and site management processes, guidelines, tools, templates, best practices, and implementation • Participate in training junior CRAs • May contribute expert input to study protocols, case report forms, and clinical monitoring plans

🎯 Requirements

• Advanced understanding of clinical research study processes, study design, and/or protocol management • Proficient knowledge of clinical trial monitoring procedures and clinical data reporting processes • Knowledge of medical terminology and anatomy/physiology • Computer proficiency with word processing, databases, email, and internet • Intermediate project management, training, and conflict resolution skills • Strong time management and problem-solving abilities • Excellent oral and written communication • Ability to manage multiple deadlines and priorities independently while ensuring quality and timeliness • Excellent attention to detail • Independent problem-solving and decision-making for complex situations with minimal guidance • Ability to analyze trends, identify issues, and escalate appropriately • Ability to adapt to change and navigate clinical research processes and stakeholders • Must exemplify NMDP values professionally • Willingness and ability 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 substituted upon evaluation • Minimum three years of experience conducting clinical research studies • At least one year of direct experience monitoring clinical research studies or managing sites and protocols from a sponsor or CRO perspective • 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