Associate iCRA

About Heart Rhythm Clinical Research Solutions

We bring science, data, and collaboration together in a single, full-service CRO model powered by real-world evidence (RWE).

By combining deep cardiovascular expertise, an engaged and diverse network of physicians, and close client partnerships, we transform data into evidence that fuels innovation and leads to better care.

Our growing network of experts and institutions powers every project we deliver — enabling collaboration,

scalability, and measurable results.

270

Cardiovascular 
Specialists

100

Signed Data Sharing Agreements

3

New Sites per Month

4

Countries represented

About The Role

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.
  
  

LOCATION AND TRAVEL 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.

This employer participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.