Clinical Research Associate Jobs

The Clinical Research Associate II serves as a key resource for the Clinical Research Department managing AVITA’s clinical trials.

Duties/Responsibilities

• Performs site selection, initiation, monitoring, and close-out visits and prepares applicable reports
• Review study protocols and study plans from an operational/monitoring perspective and provide meaningful and logical insights into their feasibility and appropriateness
• Supports the development of a subject recruitment plan and facilitates sites to meet enrollment goals
• Manages progress by tracking regulatory submissions, recruitment, case report forms (CRF) completion, and data query resolution
• Serve as the face of the company during all site interactions. Cultivate site relationships through discussions with PI and site staff. Address and/or escalate all study-related questions
• Evaluates the quality and integrity of site practices in accordance with regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Assist sites with the IRB submission and renewal process and tracks continuing IRB renewals. Ensure site compliance with IRB requirements
• Perform other duties as requested
• Assist project leads with the use of the CTMS to monitor study metrics including recruitment, site visits, data quality, patient safety, timely submission of trip visit reports, timely escalation of any monitoring quality issues, etc. Generate study-specific dashboards and reports on demand as necessary

Skills/Experience

• Commitment to excellence and high standards
• Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials
• Knowledge and proficiency with Word, Excel, Power Point, EDC systems, eTMF and CTMS
• Excellent organizational skills along with strong attention to detail and the ability to keep detailed, accurate records
• Flexibility and a proactive orientation
• Strong verbal and written communication, superior organizational and interpersonal skills
• 3 – 5 years clinical research experience in medical device, pharmaceutical industry or CRO as a CRA
• Ability to work independently and collaboratively in a dynamic, fast-paced, timeline-based environment

Education/Training

Bachelor’s degree in Biological/Health Sciences or equivalent clinical, healthcare or laboratory-related work experience is strongly preferred.

Travel Requirements

Must be willing and able to travel approximately 65%, including overnights.