Clinical Research Associate I

Job Description

POSITION SUMMARY:
This position supports the CIBMTR CRO Services team by supporting the management of one or more multi-center clinical research studies.

This position 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.

ACCOUNTABILITIES:
Monitoring:
• 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.
• With oversight and guidance, 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.

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 site personnel regarding study workflow, overcoming obstacles and general questions regarding study conduct.

Centralized Monitoring:
• Assists 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 clinical 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 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 at requested intervals
• Develops, maintains, and presents, in conjunction with senior staff, clinical trial and project specific training materials.
• Assists study related problem-solving activities internally and at trial sites.
• A...