Position Overview

The Senior In-house Clinical Research Associate (Sr. IHCRA) provides hands-on support for the day-to-day execution of clinical trial activities as assigned by Clinical Project Delivery (CPD) and/or Clinical Site and Trial Operations (CSTO).  They operate in compliance with protocols, ICH-GCP, and applicable regulation, and Standard Operating Procedures (SOPs).  

This role supports functional activities across assigned trials, sites, and vendors throughout the trial lifecycle, under the guidance and oversight of CPD and CSTO to help ensure timely, compliant trial execution.    

The person in this position may participate in cross-trial process improvement initiatives and may also provide guidance to new or more junior team members.  

Responsibilities

Project Delivery and Trial Execution Support  

• Assist with completion of assigned project delivery and clinical trial operational tasks in compliance with ICH-GCP, applicable SOPs, and protocols.  

• Help implement various study tracking tools and contribute to the development of study-level documents.  

• Maintain study timelines as assigned.  

• Assist with data review, protocol deviation review, and the query process as assigned  

• 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.