Senior Clinical Research Associate

🕒 August 11

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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 and review of essential regulatory documents • Ensure compliance with clinical trial protocols, regulations, ICH GCP guidelines, and NMDP standard operating procedures • Identify, manage, communicate, document, and resolve site findings and corrective/preventive actions • Perform query management and generate study and site status reports • Analyze issue trends and author visit reports and letters • Serve as Lead CRA, developing and monitoring study metrics, overseeing monitoring plan compliance, and escalating study risks • Oversee clinical trial site operations, site activation, study start-up, enrollment, essential documents, and electronic Trial Master File maintenance • Act as primary liaison for site management issues and support Investigators, Study Coordinators, and site staff • Train site staff on data reporting, study workflow, protocol, and regulatory compliance • Lead centralized monitoring, review study site data and reports, and develop study-specific centralized data-review processes • Track studies using CTMS and other systems, including start-up, milestones, and closeout • Develop, maintain, and present clinical trial and project-specific training materials • Assist with protocol maintenance and communications; contribute to protocols, case report forms, and clinical monitoring plans • Author and review study-specific CRF completion guidelines • Collaborate with internal and external team members to deliver high-quality trial execution • Mentor and train junior CRAs and may perform quality or performance assessment visits • Develop and continuously improve study and site management processes, tools, templates, guidelines, and best practices • Complete required training and perform other assigned duties

🎯 Requirements

• Advanced understanding of clinical research study processes, study design, and/or protocol management • Advanced knowledge of clinical trial monitoring procedures and clinical data reporting processes • Strong knowledge of medical terminology and anatomy/physiology • Computer proficiency with word processing, databases, email, and internet tools • Advanced project management, training, and conflict resolution skills • Strong time management and problem-solving abilities • Demonstrated leadership skills, collaboration, and team motivation • Ability to manage multiple deadlines and priorities independently while ensuring quality and timeliness • Excellent attention to detail • Independent problem-solving and decision-making in complex situations • Ability to analyze trends, identify issues, and escalate appropriately • Ability to adapt to change and lead clinical research processes and people • Ability to travel 25–50% domestically and internationally, occasionally up to 70% • Ability to mentor junior team members • Bachelor’s degree in a healthcare/science-related field, or equivalent related experience and/or education substituted upon evaluation • Minimum five years of experience conducting clinical research studies • At least three years of direct experience monitoring complex clinical research studies • Must exemplify NMDP values professionally • Preferred: advanced knowledge of cellular therapies, related diseases, disease assessments, and treatment complications • Preferred: direct research-site clinical study experience • Preferred: ACRP or SOCRA certification • Preferred: advanced degree in a healthcare/science-related field

🏖️ Benefits

• Medical, dental, vision, life and disability benefits • Accident, critical illness/hospital, well-being, legal, identity theft and pet benefits • Retirement benefits • Paid time off and holidays • Leave plans • Incentive plans for eligible employees