[Hiring] Associate Internal Clinical Research Associate @Heart Rhythm Clinical Research Solutions

Role Description

The Associate Internal Clinical Research Associate (iCRA) is responsible for supporting and coordinating clinical study activities in accordance with applicable regulatory guidelines, sponsor requirements, and organizational standard operating procedures. The Associate iCRA plays a key supporting role to Clinical Study Managers (CSM) by assisting with overall study management and maintaining the study electronic Trial Master File (eTMF).

The Associate iCRA plays a critical role in the project lifecycle of study start-up through close-out. The Associate iCRA ensures all activities are conducted in accordance with International Council for Harmonization Good Clinical Practice (ICH- GCP), and all other applicable regulatory requirements and guidelines.

What you'll do

• Assist with the management of study mailboxes, ensuring timely responses where needed and appropriate filing into the eTMF.
• Support preparation of protocols, case report forms, IRB/EC submissions/documents.
• Assist with site qualification and site initiation visits in collaboration with clinical operation teams.
• Support study start-up activities including but not limited to collection, review and tracking of essential documents.
• Work directly with sites to ensure all requirements are met prior to sites being activated.
• Assist with maintenance and the development of study trackers (site contacts, FAQ log, training, payment reconciliation, etc.).
• Assist with the preparation of project communications, such as newsletters and team presentations, to update stakeholders on study progress and operational status.
• Maintain the eTMF for assigned studies and ensure that they are audit ready.
• Assist with the study close-out process on a site level and study level.
• Work closely with Clinical Study Manager, Monitors, study teams, clients, and sponsor representatives to ensure seamless study execution.
• Assist with internal team meetings as required.
• Participate in process improvement initiatives, SOP updates and functional working groups.
• Participate in the development of tools and templates that benefit the broader iCRA team.
• Assist with audits and inspections.
• Perform other duties as assigned.

Qualifications

• Bachelor’s degree in life science, data science, or related field. However, a combination of experience and/or education will be taken into consideration.
• Minimum of 2 years of experience in clinical research.
• Understanding of GCP, FDA, ICH, and other regulatory requirements related to Clinical Research.
• Excellent attention to detail and problem-solving skills.
• Good communication and interpersonal skills.
• Healthy disdain for the status quo.
• Proficiency in data monitoring software and other relevant tools such as EDC.

Requirements

• This is a fully remote position and may be performed anywhere within the United States of America.
• Occasional domestic travel may be required for company meetings, audits, etc.

Company Description