Clinical Research Associate

Role Summary

The Clinical Research Associate (CRA) is responsible for supporting all aspects of clinical trial management for complex, global studies from study planning and start up through study close out. This role will collaborate with functional team members, CROs, and vendors to successfully deliver clinical studies under the direction of the Clinical Trial Manager or Director. The CRA is responsible for adherence to all performance metrics and quality of deliverables in the clinical trial. Location: On-Site 4 days per week at our Princeton, NJ or Miami, FL locations.

Responsibilities

• Directs and completes communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables
• Review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
• Initiates and builds solid professional relationships with clinical site staff
• Partners with the CRO to ensure robust ongoing data monitoring strategies carried out effectively to ensure delivery of high-quality data
• Creation and development of study trackers
• Develop and provide clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
• Responsible for the development and management of clinical trial documents including (but not limited to) consent documents, site welcome packets, study binders, etc.
• Responsible for reviewing assigned study related plans, processes, agreements, and guidelines
• Following and implementing assigned study related plans, processes, agreements, and guidelines
• Responsible for requesting and logging CRO and vendor RFIs / RFPs contracts/work orders and specifications to enable study objectives to be met
• Reviews and approves essential document packages to enable timely site activations
• Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
• Provides close oversight on the findings on the monitoring reports and loops back with broader team to provide updates as needed
• Assess and support investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary
• Responsible for oversight on the maintenance of the TMF and completeness at the end of the study. Perform periodic QC of the TMF
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs
• Ensures the study is “inspection ready” contemporaneously
• Responsible for supporting functional activities of Clinical Trial Associates allocated to the project through leadership and training as indicated and appropriate
• All other duties as assigned

Qualifications

• Preferred: Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area
• Required: A minimum of 3+ years of clinical research experience in conducting clinical trials
• Required: Prior phase II or III experience
• Required: A solid understanding of the recruitment methods, drug development process, ICH guidelines/GCP and each step within the clinical trial process
• Preferred: Experience with clinical studies oncology and/or rare diseases
• Required: Proficient use of Microsoft Outlook, Word, Excel, and Teams
• Required: Ability to travel internationally to visit clinical sites and for study meetings (up to 20%)
• Required: Tenacity to work in a fast-paced team environment
• Required: Builds relationships with KOLs and site personnel and is willing to travel to establish relationships
• Required: Ability to work collaboratively with global team members and to support patient enrollment strategies
• Required: Excellent interpersonal and decision-making skills, drive and enthusiasm to deliver program objectives
• Required: Ability to review and assess clinical data; strong planning, time management, and coordination skills
• Required: Problem-solving ability and clear judgment regarding regulatory requirements and timelines
• Preferred: Experience in a small organization
• Required: Excellent written and oral communication skills

Skills

• Strong communication and relationship-building with site staff and CROs
• Data monitoring and quality assurance capabilities
• Documentation management and TMF oversight
• Project coordination and cross-functional collaboration
• Proficient in MS Office and collaboration tools
• Global travel readiness

Education

• Bachelor’s degree or equivalent in life sciences or related field (preferred)

Additional Requirements

• Travel: Ability to travel internationally to visit clinical sites and for study meetings; up to 20% depending on project needs