Clinical Research Associate II

Responsibilities

Independently perform full-scope remote and on-site monitoring visits involving source document verification, review of essential regulatory documents, and assessing site performance

Ensure compliance with clinical trial protocols based on regulations, ICH GCP guidelines, and NMDP standard operations procedures

Identify and communicate site findings with site study personnel and the study team

Perform query management activities and generate study and site status reports

Independently analyze trends in identified issues and author visit reports and letters. Ensures documentation and resolution of identified issues and implementation of corrective and preventative action

May serve as Lead CRA on studies with multiple assigned CRAs, including developing and monitoring of study metrics, overseeing clinical monitoring plan compliance and escalating study risk, with supervision

Oversee and manage operational aspects of clinical trial sites in conjunction with project teams

Assists with site activation and ensures study start-up and enrollment goals are met

Collect and review essential documents for investigational sites, including maintenance of electronic Trial Master File

Serves as primary liaison for site management issues for assigned studies, escalating to the clinical project manager as required

Utilizes effective and proactive communication, relationship building, and issue management to develop and maintain good working relationships with Investigators and site staff

Provide support to Investigators, Study Coordinators, and other appropriate staff personnel regarding study workflow, overcoming obstacles, and general questions regarding study conduct

Leads and trains others in reviewing study site data and data reports to ensure timely and accurate submission and compliance with the study protocol

Performs all duties in compliance with standard operating procedures, regulations outlined in the Code of Federal Regulations (CFR), ICH GCP guidelines, Federal Drug Administration (FDA) guidance and other applicable Federal, state, and local laws

Assist and train other CRAs in user acceptance testing (UAT) of clinical database management system for individual clinical trials

Performs study tracking (e.g., CTMS, start-up, milestone, closeout); generates, reviews, and distributes management reports from internal tracking systems proactively and at requested intervals

Develops, maintains, and presents, in conjunction with senior staff, clinical trial and project specific training materials

Leads study related problem-solving activities internally and at trial sites

Assists in protocol maintenance, tracking, and communications

Works with internal and external team members to deliver high quality trial execution

Participates in shared team responsibilities, ensuring optimal coverage of trials

Participates in NMDP, CIBMTR, or CIBMTR CRO Services project teams as needed

Complete and maintain all training requirements

Develop, maintain, and continuously improve study and site management processes, guidelines, tools, templates, best practices, and overall implementation

Participates in training junior CRAs on moderately complex concepts, processes, and tasks

May participate in the development of study protocols, case report forms, and clinical monitoring plan and provides expert input

Other duties as assigned

Preferred

Functional knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications

Direct experience working at research sites on clinical studies, with or without direct interaction with patients

ACRP or SOCRA certification

Benefits

Medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits for regular, full-time employees.

Retirement, paid time off/holidays, leave and incentive plans for eligible employees.

Glassdoor

4.0

Global nonprofit advancing blood stem cell transplants and cell therapy.

Minneapolis, Minnesota, USA

https://www.nmdp.org

Late Stage

Leadership Team

Jessica Kowal

Chief Philanthropy Officer

Steven Devine

Chief Medical Officer

Recent News

GlobeNewswire

NMDP Teams Up with Boozer Brothers to Help More Patients Access Blood Stem Cell Transplants

2026-06-18

Business Wire

NMDP Celebrates Public-Private Partnership with HRSA in Expanding Patient Access to Life-Saving Bone Marrow and Cord Blood Transplant

2026-06-04

Twin Cities

Business people: Basilica pastor Daniel Griffith to lead St. Thomas Mission office

2026-03-23

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Qualifications

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

Medical terminology and anatomy/physiology

Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of internet

Intermediate project management, training, and conflict resolution skills

Strong time management skills and problem-solving abilities

Demonstrate excellent oral and written communication

Manage multiple deadlines and priorities independently while ensuring quality and timeliness

Perform tasks requiring excellent attention to detail

Demonstrate independent problem-solving and decision-making, with minimal guidance for complex situations

Analyze trends, identify issues, and escalate as appropriate

Adapt to change

Navigate processes and people involved in clinical research, demonstrating organizational awareness and interpersonal skills necessary to complete work efficiently

Must exemplify our NMDP values in a highly professional manner in all settings

Travel 25-50%, both domestic and international, depending on assigned studies. Travel at times may increase up to 70% as required

Bachelor's degree in healthcare/science related field; however, upon evaluation, equivalent related experience and/or education may be substituted for the scientific or health-related degree requirement

Minimum of three years of experience in conducting clinical research studies, with at least one year of direct experience in monitoring clinical research studies or managing sites and protocols, either from a sponsor or CRO perspective

Functional knowledge of cellular therapies, diseases treated by cellular therapies, disease assessments, and common treatment complications

Direct experience working at research sites on clinical studies, with or without direct interaction with patients

ACRP or SOCRA certification

Minimum of three years of experience in conducting clinical research studies, with at least one year of direct experience in monitoring clinical research studies or managing sites and protocols, either from a sponsor or CRO perspective.

Required skills

Clinical Research Study Management, Clinical Trial Monitoring, Clinical Data Reporting, Study Design and Protocol Management, Medical Terminology, Anatomy and Physiology, ACRP or SOCRA Certification, Cellular Therapies

Preferred skills

ACRP or SOCRA certification

Experience

3+ years