Clinical Research Associate

2 days ago

Macquarie Park, Australia MSD Full time

**Clinical Research Associate**
- Exciting opportunity to **work directly with a Global Biopharma**
- **Permanent Full-Time** role based in Macquarie Park, Sydney Australia or Auckland, Newmarket, New Zealand
- Great opportunity to work on **innovative trials**

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

**The Opportunity**

The role is accountable for performance and compliance for assigned protocols and sites in a country.
Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations our company’s policies and procedures, quality standards and adverse event reporting requirements internally and externally.

You will be required to act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participate in internal meetings and workstreams as SME for monitoring processes and systems.

**What You Will Do**

**Responsibilities include, however not limited to**:
**What You Will Do**

**Responsibilities include, however not limited to**:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.

**Performs remote and on-site monitoring & oversight activities using various tools to ensure**:

- Data generated at site are complete, accurate and unbiased.
- Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs co-monitoring visits where appropriate.
- Following the country strategy defined by CRD and/or CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week.

**What You Must Have**
- Preferred: B.A./B.S. with strong emphasis in science and/or biology
- Prior extensive experience of direct site management (monitoring) experience in a bio/pharma/CRO
- Current driver’s license required
- Positive mindset, growth mindset, capable of working independently and being self-driven

Demonstrates and projects professional conduct and communication consistent with organizational policies and practices
- Proven skills in Site Management including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgment

**What You Can Expect**
- Be exposed to **innovative** **clinical trials**:

- Work witha **passionate **and **supportive ANZ Team**:

- **Work within a company **that truly takes **pride** on their **purpose **of **“Patients first, Profits Later”**

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the sc

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