Clinical Research Associate - Imaging

Who we are:

Optiscan Imaging Inc. is a global leader in the development of microscopic imaging and related technologies for surgery and medical research. Based in Melbourne, Australia, Optiscan was established in 1994 and listed on the ASX in 1997. We have developed and patented endomicroscopic technology which enables real-time, 3D, ‘in vivo’ imaging of human tissue at the cellular level – enabling instant virtual biopsies for cancer screening, diagnosis and treatment.

We have a strong purpose of transforming people’s lives through the earlier and less invasive diagnosis and treatment of cancer and are on a journey to achieve this globally.

Work with us:

As an employer, we take pride in empowering and developing our people to be the best they can be. By joining Optiscan, you will have the opportunity to showcase your clinical research skills and will play a critical role in collecting and analyzing imaging data on our global clinical team.

Job Summary:

The Clinical Research Associate (Imaging) is a key contributor to the success of clinical research initiatives within both hospital and pathology laboratory environments. This role is primarily responsible for performing a variety of imaging procedures and analyzing resultant data generated in various clinical studies, trials and research projects. The incumbent must ensure that all activities are conducted in strict adherence to Optiscan’s code of conduct, as well as all relevant organizational policies and procedures. The position requires a high level of professionalism, technical expertise, and a commitment to ethical clinical research practices.

Key Responsibilities:

1. Imaging Procedures:

Conduct a range of imaging procedures in both hospital and pathology laboratory settings. This includes preparing equipment, calibrating imaging devices, and following established protocols and safety guidelines to ensure high-quality, reproducible results. The role involves working with advanced microscopic imaging technologies and adapting procedures to meet the specific requirements of each clinical study.

2. Research Data Management:

Assist in the comprehensive preparation, collection, documentation, and analysis of research data related to clinical imaging studies. This involves maintaining meticulous records, entering data into secure databases, and ensuring that all data is accurate, complete, and compliant with regulatory standards.

3. Clinical Trial Coordination:

Support the planning and execution of clinical trial activities. This includes assistance with recruiting and screening participants, obtaining informed consent, scheduling and coordinating imaging sessions, liaising with clinicians, surgeons or pathologists involved in clinical studies, and ensuring participants are well-informed and comfortable throughout the process.

4. Data Integrity and Confidentiality:

Maintain the highest standards of data integrity and confidentiality. This means safeguarding sensitive clinical and laboratory data, following data protection protocols, and ensuring that all information is handled in accordance with legal and ethical requirements.

5. Team Collaboration:

Work collaboratively with multidisciplinary teams, including clinicians, pathologists, research scientists, and administrative staff. Effective communication and teamwork are essential to facilitate smooth workflow, resolve issues promptly, and achieve research objectives.

6. Compliance and Ethics:

Ensure full compliance with all ethical, legal, and regulatory requirements relevant to clinical research and imaging practices. This includes adhering to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and any applicable ISO or FDA regulations.

Your Profile:

Research Experience:

At least three years of experience in biological research, which may include holding a PhD, working as a research assistant (with responsibilities such as performing experiments and designing protocols), experience in a microscopy facility, or working as a technician in a laboratory setting.

Clinical Research Experience:

At least two years of experience working in a clinical research environment, ideally within hospital or pathology laboratory settings, is highly desirable.

Regulatory Knowledge:

Knowledge and practical application of current ISO 14155, ISO 13485, GCP, ICH, and FDA regulations and guidelines in clinical trials is advantageous.

Software Skills:

Experience with biological software programs such as Endnote, PRISM, ImageJ, Adobe Illustrator, and Photoshop and clinical trial management software is considered an asset.

Willingness to Travel:

Be willing and able to travel locally as required to support clinical trial and research activities.

Organizational and Communication Skills:

Demonstrate strong organizational abilities and excellent communication skills, with the capacity to work independently as well as collaboratively within a team.

Attention to Detail:

Exhibit a keen attention to detail and a strong commitment to maintaining high standards of data integrity and patient confidentiality.

Qualifications:

Educational Background: Possess a relevant qualification, preferably at the tertiary level, in a scientific, medical, or allied health discipline.

Good Clinical Practice (GCP) certification is advantageous.

If you desire to work with a company that makes a difference in patient outcomes and are looking to join a friendly, progressive company built on innovation, apply below with a cover letter and resume describing how you have demonstrated the attributes we are looking for.

We recognize the value of diversity in our workplace and strive to promote fairness and equal employment opportunity.

Job Types: Full-time, Contract

Pay: $80,000.00 - $90,000.00 per year

Benefits:

• Paid time off

Work Location: In person