Clinical Research Associate

Essential Responsibilities:

• Perform pre-study, initiation, interim monitoring, and close-out visits according to applicable SOPs, GCP, and FDA Guidelines.
• Monitors clinical studies at a site level, including the review of case report forms (CRFs) to ensure adherence to the current protocol and consistency and scientific validity of the data as verified against source document data
• Manages all aspects of a clinical study at assigned clinical trial sites to ensure subject safety, adherence to appropriate safety regulations, and data integrity.
• Coordinates the collection and approval of essential and regulatory documents and maintenance of site study documentation.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion. Provides technical, scientific, and operational guidance to study site personnel on the protocol.
• Tracking and managing IP and trial materials for clinical sites.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Writing visit reports and implementing action plans for sites not meeting expectations.
• Input and manage clinical research data into electronic data systems
• Ensure the study site is compliance with all local and federal laws and regulations
• Assists with the tracking and reporting of enrollment and works with the site to identify enrollment issues, barriers, and strategies.
• Implements project-specific processes and tools.
• Performs other tasks as directed by line management or project leadership.

Experience & Preferred Qualifications:

• Five plus years working as a CRA within either pharma or biotech setting
• Experience working within electronic systems such as Xcel, MS Project, Outlook, Power Point as well as experience in study related systems such as Electronic Data Capture, Trial Master File, Interactive Response Technology and more, as applicable
• Ability to manage and prioritize workload effectively.
• Experience with IATA shipping requirements, FDA and ICH/GCP regulations and their practical implementation.
• Willingness to travel, up to 50% domestic travel with possibility international travel as needed. Travel may be on short notice.
• In-house position, New Haven, Connecticut
• Full time 40-hour work week required.
• Self-starter who demonstrates initiative and ability to drive projects and deadlines forward.
• Capacity for teamwork and desire to work collaboratively.
• Strong written and verbal communication skills. Ability to keep detailed and accurate records with strong organizational skills.
• Sound judgment and problem-solving mindset.
• Valid drivers’ license, own reliable transport and up to date car insurance