Clinical Research Associate II

POSITION SUMMARY:

This position supports the CIBMTR CRO Services team supporting and leading the management of one or more multi-center clinical research studies. This position independently performs site monitoring visits to complete source document verification and assess site compliance. Additionally, this position is responsible for coordinating and providing support for all aspects of the study including protocol and site management, providing training to junior team members, and demonstrates comprehensive knowledge of the monitoring functions.

ACCOUNTABILITIES:

Monitoring:

• 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.

Site Management:

• 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.

Centralized Monitoring:

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

Other Duties as Required for Clincal Operations:

• 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.

REQUIRED QUALIFICATIONS:

Knowledge of:

• 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.

Ability to:

• 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.

Education and/or Experience:

• 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.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• 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.