Associate Clinical Research Associate

Job Description

Associate CRA (aCRA)

• Permanent, full-time role with competitive remuneration and benefits

• Location:  Macquarie Park, Sydney, Australia

• Career growth: Expand your expertise in a growing, successful industry

• Professional development: Gain valuable experience in a dynamic, evolving role

With support from the Senior CRA, CRA, and/or CRA Manager, the Associate CRA acts as the primary site contact throughout all phases of a clinical research study and takes responsibility for allocated sites. This role is central to building strong site relationships, supporting study delivery, and ensuring monitoring activities are completed in line with clinical research standards, applicable regulations, and sponsor requirements.

Working across study start-up, site management, monitoring, and close-out, you will collaborate with internal and external stakeholders to help ensure high-quality, compliant study conduct and the protection of subject rights, safety, and well-being. This is a field-based role requiring regular domestic travel and occasional international travel.

What You Will Do

Responsibilities include, however not limited to:

• Act as the primary site contact and site manager for allocated clinical research sites

• Develop strong site relationships and maintain continuity throughout all phases of the trial

• Perform site management and monitoring activities in compliance with ICH-GCP, sponsor procedures, local laws and regulations, protocol requirements, site monitoring plans, and related documents

• Develop an in-depth understanding of the study protocol and associated procedures

• Coordinate and manage site readiness activities in collaboration with other sponsor functions

• Participate in site selection and site validation activities

• Conduct remote and on-site monitoring and oversight activities to ensure data quality and subject safety

• Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits

• Prepare clear, accurate, and timely visit reports and non-visit contact reports

• Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out

• Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits, inspections, and site performance

• Identify, assess, and resolve site performance, quality, and compliance issues and escalate as required

• Work in partnership with internal functions and external stakeholders including vendors, IRBs or IECs, and regulatory authorities

• Maintain information and documentation accurately in clinical systems such as CTMS and eTMF

• Support audit and inspection activities as needed

• Perform co-monitoring where appropriate

• Travel domestically and internationally approximately 65% to 75% of working time, with expected travel of around 2 to 3 days per week

What You Must have

• Associate degree, certificate, or equivalent in a scientific or healthcare discipline with relevant healthcare experience, or a bachelor’s degree in a scientific or healthcare discipline, or a bachelor’s degree in a non-scientific discipline with relevant healthcare experience

• Good understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and applicable country clinical research laws and guidelines

• Working knowledge of Global and Country or Regional CRA guidelines

• Hands-on knowledge of Good Documentation Practices

• Developing site management capability, including site performance and patient recruitment

• Developing monitoring capability and independent professional judgment

• Strong IT skills, including Microsoft Office and clinical systems used on computers, tablets, and mobile devices

• Ability to adapt quickly to new technology and systems

• Strong quality and compliance mindset

• Ability to manage complex issues using a solution-oriented approach

• Ability to perform root cause analysis and support corrective and preventive actions

• Fluent in local language and English, with strong verbal and written communication skills

• Effective time management, organisational, interpersonal, and conflict management skills

• Ability to work independently while developing skills across multiple protocols, sites, and therapy areas

• Strong accountability, urgency, and ability to manage multiple priorities in a changing environment

• Experience working effectively in a matrix, multicultural environment

• Customer-focused mindset and professional demeanour

What You Can Expect

• The opportunity for a hands-on role in clinical research delivery across a variety of sites and therapy areas

• Exposure to site management, monitoring, and regulatory activities in a highly regulated environment

• Strong support from the monitoring team and study teams as you continue to develop your monitoring capability

• A collaborative, matrixed environment where professionalism, accountability, and quality matter

• Significant travel and the opportunity to build broad clinical research experience

• Requires domestic and international travel approximately 65%–75% of working time

We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive workplace.

#LI-DNI

Required Skills:

Accountability, Adverse Event Report, Clinical Documentation, Clinical Evaluation Reports, Clinical Reporting, Clinical Research, Clinical Research Methods, Clinical Trial Development, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Medical Terminology, Protocol Adherence, Regulatory Compliance, Status Reporting

Preferred Skills:

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

N/A

Job Posting End Date:

08/21/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.