Clinical Trials Assistant

East Sydney Doctors is a busy, privately owned general practice located in Darlinghurst, conveniently close to Sydney’s CBD and public transport. We are committed to providing high-quality, patient-centred healthcare and have a dedicated and expanding Clinical Trials Department.

We are seeking an enthusiastic and experienced Clinical Trials Assistant to join our team. This is an excellent opportunity for someone with clinical trials experience who is looking to further develop their skills, with the potential for progression into a Clinical Trials Coordinator role.

Part-time or full-time hours will be considered for the right candidate.

About the role

The purpose of this role is to support the care, safety and coordination of patients participating in clinical trials, while assisting the Principal Investigator and Clinical Trials Team with the collection, management and accurate recording of trial data.

You will work closely with the Principal Investigator, research team, patients, sponsors and Clinical Research Associates to ensure studies are conducted efficiently, accurately and in accordance with study protocols and Good Clinical Practice (GCP).

Key responsibilities

·         Work closely with the Principal Investigator and Clinical Trials Team to manage the day-to-day activities of clinical trials.

·         Assist with problem-solving, communication and protocol management.

·         Build strong, professional relationships with patients participating in clinical trials.

·         Conduct trial activities in accordance with GCP guidelines, study protocols and regulatory requirements.

·         Assist with obtaining, documenting and maintaining informed consent.

·         Complete accurate and timely data entry, data queries and quality assurance checks.

·         Liaise with Clinical Research Associates and Sponsor Representatives.

·         Monitor, document and proactively follow up adverse events in accordance with study requirements.

·         Collect, process, label, handle and store clinical samples in accordance with trial protocols.

·         Coordinate and manage the logistics of study visits.

·         Maintain accurate and complete study records and documentation.

·         Maintain Investigator Site Files within SiteDocs – full training will be provided.

·         Maintain patient confidentiality and privacy at all times.

·         Assist the broader Clinical Trials Team to ensure studies remain organised, compliant and on schedule.

About you

·         Nursing qualifications or a degree in science, health science or another relevant healthcare discipline.

·         Previous experience working within a clinical trials or clinical research environment.

·         Knowledge and understanding of Good Clinical Practice (GCP).

·         A strong understanding of the importance of patient confidentiality, privacy and ethical clinical research.

·         Excellent verbal and written communication skills.

·         Strong interpersonal skills and the ability to develop positive relationships with patients, colleagues, investigators and sponsors.

·         Excellent attention to detail and a proactive approach to your work.

·         Strong organisational and time-management skills, with the ability to manage competing priorities and meet deadlines.

·         The ability to work independently while also being a collaborative and supportive team member.

·         Experience with Electronic Data Capture (EDC) systems, such as iMedidata RAVE, InForm or similar, would be highly desirable.

·         A professional, approachable and positive attitude.

Why join us?

This is an opportunity to join an established and growing clinical trials team within a busy private general practice environment.

You will work alongside experienced clinicians and research staff and have the opportunity to broaden your clinical research knowledge and develop your career, with potential progression into a Clinical Trials Coordinator position.

We value people who are reliable, organised, compassionate and genuinely interested in delivering high-quality clinical research and patient care.

How to apply

Please submit both a current CV and cover letter addressed to CEO Heather Farlow:

••••@eastsydneydoctors.com.au

Applications will be reviewed as they are received. Only applicants who meet the selection criteria will be considered for interview.

Only Australian citizens and permanent residents need apply.