Clinical Research Associate II

This position supports the CIBMTR CRO Services team, leading and managing one or more multi-center clinical research studies. The role involves independently performing site monitoring visits, ensuring compliance, coordinating study aspects, and providing training to junior team members.

Responsibilities

• Independently perform full-scope remote and on-site monitoring visits, including source document verification, review of essential regulatory documents, and assessing site performance.
• Ensure compliance with clinical trial protocols, ICH GCP guidelines, NMDP standard operating procedures, and applicable regulations.
• Identify and communicate site findings with site study personnel and the study team; perform query management activities and generate study and site status reports.
• Analyze trends in identified issues and author visit reports and letters; ensure documentation and resolution of issues and implementation of corrective and preventative actions.
• May serve as Lead CRA on studies with multiple assigned CRAs, including developing and monitoring study metrics, overseeing clinical monitoring plan compliance, and escalating study risks with supervision.
• Oversee and manage operational aspects of clinical trial sites in conjunction with project teams; assist with site activation and ensure study start-up and enrollment goals are met.
• Collect and review essential documents for investigational sites, including maintenance of the electronic Trial Master File.
• Serve as primary liaison for site management issues for assigned studies, escalating to the clinical project manager as required.
• Utilize effective communication, relationship building, and issue management to develop and maintain working relationships with Investigators and site staff.
• Provide support to Investigators, Study Coordinators, and other staff regarding study workflow, overcoming obstacles, and general questions about study conduct.
• Lead and train others in reviewing study site data and reports to ensure timely and accurate submission and compliance with the study protocol.
• Perform all duties in compliance with standard operating procedures, CFR, ICH GCP guidelines, FDA guidance, and other applicable laws.
• Assist and train other CRAs in user acceptance testing (UAT) of clinical database management systems for individual clinical trials.
• Perform study tracking (e.g., CTMS, start-up, milestone, closeout); generate, review, and distribute management reports from internal tracking systems.
• Develop, maintain, and present clinical trial and project-specific training materials in conjunction with senior staff.
• 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.
• Participate 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.
• Train junior CRAs on moderately complex concepts, processes, and tasks; may participate in the development of study protocols, case report forms, and clinical monitoring plans.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in a healthcare/science-related field; equivalent related experience and/or education may substitute for the 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.
• 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, including standard software (word processing, databases, email) and internet use.
• Intermediate project management, training, and conflict resolution skills.
• Strong time management skills and problem-solving abilities.
• Excellent oral and written communication skills.
• Ability to manage multiple deadlines and priorities independently while ensuring quality and timeliness.
• Excellent attention to detail; ability to demonstrate independent problem-solving and decision-making with minimal guidance for complex situations.
• Ability to analyze trends, identify issues, and escalate as appropriate.
• Adaptability to change and strong organizational awareness and interpersonal skills.
• Must exemplify NMDP values in a highly professional manner in all settings.

Preferred Qualifications

• 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.

Schedule

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

Benefits

• Medical, dental, vision, life, and disability insurance.
• Accident, critical illness, hospital, well-being, legal, identity theft, and pet benefits.
• Retirement plans, paid time off, holidays, leave, and incentive plans.

For more information, visit: NMDP Benefit Information.