Senior Clinical Research Associate

🔥 10 minutes ago

❄️ Minnesota – Remote

❄️ Minnesota – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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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, and communicate site findings; manage queries; and generate study and site status reports • Analyze issue trends, author visit reports and letters, ensure issue resolution, and implement corrective and preventative actions • Serve as Lead CRA on multi-CRA studies, managing study metrics, monitoring-plan compliance, and study-risk escalation • Oversee clinical trial site operations, support site activation, and help meet start-up and enrollment goals • Collect and review essential site documents and maintain the electronic Trial Master File • Act as primary liaison for site-management issues and support Investigators and study staff with study conduct and workflow • Train site staff on complex data reporting, protocol compliance, and regulatory compliance • Lead centralized review of site data and data reports and develop study-specific centralized-review processes • Track studies and milestones using systems such as CTMS; generate, review, and distribute management reports • Develop, maintain, and present clinical trial and project-specific training materials • Lead internal and site-level study problem-solving activities • Assist with protocol maintenance and communications; contribute to study protocols, case report forms, clinical monitoring plans, and CRF completion guidelines • Support user acceptance testing of clinical database management systems • Collaborate with internal and external team members to deliver high-quality trial execution • Mentor junior CRAs and lead or participate in NMDP, CIBMTR, and CIBMTR CRO Services project teams • Maintain training requirements and continuously improve study and site-management processes, tools, templates, guidelines, and best practices • Perform Quality or Performance Assessment Visits as needed • Perform other duties as assigned

🎯 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 use • Advanced project management, training, and conflict resolution skills • Strong time management and problem-solving abilities • Demonstrated leadership skills, collaboration, and ability to motivate team members • Ability to manage multiple deadlines and priorities independently while ensuring quality and timeliness • Excellent attention to detail • Independent problem-solving and decision-making, including in complex situations • Ability to analyze trends, identify issues, and escalate appropriately • Adaptability to change • Ability to lead clinical research processes and people with organizational awareness and interpersonal skills • Ability to travel 25–50% domestically and internationally, with travel occasionally increasing 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 • Preferred: advanced knowledge of cellular therapies, related diseases, disease assessments, and treatment complications • Preferred: direct experience working at research sites on clinical studies • Preferred: ACRP or SOCRA certification • Preferred: advanced degree in a healthcare/science-related field

🏖️ Benefits

• Medical benefits • Dental benefits • Vision benefits • Life insurance • Disability benefits • Accident benefits • Critical illness benefits • Hospital benefits • Well-being benefits • Legal benefits • Identity theft benefits • Pet benefits • Retirement plans • Paid time off and holidays • Leave plans • Incentive plans