Clinical Research Associate (CRA)

Merck; Neuseeland; Vor Ort; NZD 70.000 - 110.000; Vollzeit

Zusammenfassung

Merck in Auckland, New Zealand, is seeking aClinical Research Associate (CRA) to ensure site performance, compliance with ICH-GCP, and robust data integrity across assigned protocols. The role reports to the CRA Manager and focuses on site management, regulatory documentation, and investigator collaboration.

You will monitor sites, support start-up and close-out activities, and help grow the clinical research territory while collaborating with cross-functional teams to uphold quality and patient

Qualifikationen

• For this CRA role, direct site management experience in bio/pharma/CRO is required.
• Strong knowledge of GCP/ICH requirements and local regulatory guidelines.
• Hands-on documentation practices and regulatory file handling.
• Proven monitoring capability and ability to work independently.
• Ability to manage multiple sites, protocols, and timelines with accuracy.
• Fluent in local language and English, with strong written communication.

Aufgaben

• Act as primary site contact and site manager for allocated sites.
• Develop and maintain strong site relationships across trial phases.
• Perform site management and monitoring in compliance with ICH-GCP and protocol.
• Coordinate site readiness activities with sponsor functions.
• Participate in site selection and validation activities.
• Conduct remote and on-site monitoring to ensure data integrity and safety.
• Prepare visit reports and regulatory documentation for start-up, maintenance, and close-out.
• Communicate with investigators and site staff on protocol conduct and audits.

Kenntnisse

Site management

Monitoring

ICH-GCP compliance

Data interpretation

Communication

Time management

Independent judgment

Problem solving

Ausbildung

Associate degree / certificate in scientific or healthcare discipline

Bachelor’s degree or higher in science/healthcare

Tools

CTMS

eTMF

MS Office

Jobbeschreibung

Clinical Research Associate (CRA)

Permanent, full-time role with competitive remuneration and benefits

Location: Auckland, New Zealand

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

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

As a Clinical Research Associate, you will be accountable for the performance and compliance of assigned protocols and sites within a country. Reporting to the CRA Manager, you will ensure study conduct aligns with ICH-GCP, local regulations, company policies and procedures, quality standards, and adverse event reporting requirements.

This role acts as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. You will also contribute to territory growth by identifying and developing new sites, while sharing best practices and supporting monitoring capability within the wider CRA team.

What You Will Do

• Act as the primary site contact and site manager for allocated clinical research sites
• Develop and maintain strong site relationships 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 integrity and subject safety
• Conduct site visits including validation visits, initiation visits, monitoring visits, and close-out visits
• Prepare clear, comprehensive, 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 elevate as required
• Work in partnership with internal and external stakeholders including country operations, finance, regulatory affairs, pharmacovigilance, legal, vendors, IRBs or IECs, and regulatory authorities
• Maintain information and documentation accurately in CTMS, eTMF, and other relevant systems
• Contribute to CRA team knowledge by acting as a subject matter expert, buddy, or mentor and sharing best practices
• Support and/or lead audit and inspection activities as needed
• Perform co-monitoring visits where appropriate
• Identify and develop new potential sites in line with country strategy and support the development of strong clinical research capability

What You Must have

• Associate degree, certificate, or equivalent in a scientific or healthcare discipline with relevant healthcare experience, including direct site management experience in a bio, pharma, or CRO environment, or a bachelor's degree or above with direct site management experience in a bio, pharma, or CRO environment
• Strong understanding of clinical research, clinical trial phases, current GCP and ICH requirements, and country clinical research laws and guidelines
• Working knowledge of Global and Country or Regional Clinical Research Guidelines
• Hands-on knowledge of Good Documentation Practices
• Proven site management capability, including site performance and patient recruitment
• Demonstrated monitoring capability and independent professional judgment
• Strong IT skills, including Microsoft Office and a range of clinical applications across computer, tablet, and mobile devices
• Ability to interpret data and metrics and act appropriately
• Ability to manage complex issues in a solution-oriented manner
• Ability to perform root cause analysis and implement corrective and preventive actions
• Fluent in local language and English, with strong verbal and written communication skills
• Effective time management, organisational, interpersonal, problem-solving, and conflict management skills
• Ability to work highly independently across multiple protocols, sites, and therapy areas
• Strong accountability, urgency, and ability to manage multiple priorities in a changing environment
• Ability to work effectively in a matrix, multicultural environment
• Strong customer focus and professional demeanour
• Positive, self-driven, and growth-oriented mindset

What You Can Expect

• The opportunity to own and influence assigned sites across a national clinical research portfolio
• Exposure to site management, monitoring, start-up, and close-out activities in a highly regulated environment
• The chance to help grow the clinical research territory by identifying and developing new sites
• A collaborative, mat