Senior In-House Clinical Research Associate

• Contribute to the development, maintenance and quality control of trial documentation, including study manuals, plans, protocols, instructions, trackers, worksheets, and presentations.  

• Help ensure completeness, maintenance, and quality of the Trial Master File.  

Site Management and Monitoring Support  

• Support site management and monitoring activities as assigned, including tasks related to site selection and activation, investigational product (IP) and clinical supplies management, site monitoring visit preparation, site-level Informed Consent review, and site contracts management.  

• Help develop, distribute, review, track, and file essential documents and study binder documents, troubleshooting related issues to ensure on time delivery at all stages.  

•  Maintain site- and participant-level tracking.  

• Support data cleaning activities as assigned  

Vendor Management Support  

• Assist with day-to-vendor management activities including tracking and workflow management of vendor contracts.  

• Support change order and change notification tracking, as assigned.  

• May serve as day-to-day vendor contact for assigned activities.  

• Participate in vendor teleconferences, record meeting minutes, track action items and decisions.  

• Assist with invoice review and budget tracking.  

Cross-Functional Collaboration  

• Collaborate with the clinical study team members as assigned to support consistency and efficiency of trial execution.  

• Develop and maintain positive, effective, and collaborative working relationships with team members and vendors.  

• Help onboard and guide new or junior team members.  

Qualifications

• Bachelor’s degree with 3 years of clinical project or trial management experience in the biotechnology or pharmaceutical industry, or an equivalent combination of education and experience.  

• Demonstrated experience with site management and vendor management activities, including CROs and central labs.   

• Demonstrated experience with trial documentation and Trial Master File management. 

Knowledge and Skills

• Working knowledge of clinical trial processes, and ICH-GCP.  

• Strong organizational skills with the ability to manage multiple competing tasks.  

• Ability to effectively work cross-functionally and build relationships with stakeholders without direct authority.  

• Strong communication and interpersonal skills.  

• Detail-oriented with an analytical approach to problem-solving.  

• Able to prioritize and manage multiple tasks and projects in a fast-paced, dynamic environment.  

• Highly professional, adaptable, and accountable.