Clinical Research Associate I

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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

• Support management of one or more multi-center clinical research studies for the CIBMTR CRO Services team • Perform full-scope remote and on-site monitoring visits, including source document verification and review of essential regulatory documents • Assess site performance and ensure compliance with clinical trial protocols, regulations, ICH GCP guidelines, and NMDP standard operating procedures • Identify and communicate site findings; manage queries; generate study and site status reports • Analyze trends, author visit reports and letters, and ensure issue resolution and corrective and preventative action • Oversee operational aspects of clinical trial sites with project teams • Assist with site activation, study start-up, enrollment goals, essential document collection, and electronic Trial Master File maintenance • Serve as primary liaison for site management issues and support Investigators, Study Coordinators, and site personnel • Review study site data and reports for timely, accurate submission and protocol compliance • Assist with clinical database management system user acceptance testing • Track studies and milestones; generate, review, and distribute management reports • Develop, maintain, and present clinical trial and project-specific training materials • Assist with protocol maintenance, tracking, communications, and study-related problem-solving • Collaborate with internal and external team members to deliver high-quality trial execution • Participate in project teams and shared team responsibilities • Complete training requirements and improve study and site management processes, tools, templates, and best practices

🎯 Requirements

• Bachelor’s degree in a healthcare/science-related field; equivalent related experience and/or education may substitute for the degree requirement • Minimum two years’ experience conducting clinical research studies according to ICH GCP guidelines and/or verifying clinical data from medical records • Knowledge of clinical research study processes, study design, and protocol management • Knowledge of medical terminology and anatomy/physiology • Computer proficiency with word processing, databases, email, and internet use • Training and conflict resolution skills • Time management and problem-solving abilities • Excellent oral and written communication • Ability to manage multiple deadlines and priorities while ensuring quality and timeliness • Excellent attention to detail • Independent problem-solving and decision-making for straightforward situations, with guidance for complex situations • Ability to analyze trends, identify issues, and escalate appropriately • Ability to adapt to change and navigate clinical research processes and stakeholders • Willingness and ability to travel 25–50% domestically and internationally, potentially up to 70% • Must exemplify NMDP values in a highly professional manner • ACRP or SOCRA certification is preferred, not required