临床研究助理
Clinical Research Associate
职位描述
**临床研究助理（CRA）**
- **长期全职岗位**，提供具有竞争力的薪酬和福利
- **工作地点：** 澳大利亚悉尼Macquarie Park - 根据所在地情况，可在家或办公室办公
- **职业发展：** 在一个不断增长、成功的行业中拓展你的专业技能
- **专业发展：** 在一个动态、不断发展的岗位中获得宝贵经验
作为临床研究助理，你将对所负责的试验方案和站点在国家范围内的表现和合规性负责。向CRA经理汇报，你将确保研究的进行符合ICH-GCP、当地法规、公司政策和程序、质量标准以及不良事件报告要求。
该职位在整个临床研究试验的各个阶段都是主要的站点联系人和站点管理者，对分配的站点负有全面责任。你还将通过识别和开发新站点来促进区域发展，同时与更广泛的CRA团队分享最佳实践并支持监查能力。
**你将负责以下工作**
**职责包括但不限于：**
- 作为分配的临床研究站点的主要联系人和站点管理者
- 在整个试验阶段建立并维护良好的站点关系
- 按照ICH-GCP、赞助方程序、当地法律法规、方案要求、站点监查计划及相关文件的要求，执行站点管理和监查活动
- 深入理解研究方案及相关流程
- 与其他赞助方职能协作，协调和管理站点准备活动
- 参与站点选择和站点验证活动
- 执行远程和现场监查及监督活动，以确保数据完整性和受试者安全
- 进行站点访问，包括验证访问、启动访问、监查访问和结题访问
- 准备清晰、全面且及时的访问报告和非访问联系报告
- 收集、审查和监控研究启动、维持和结题阶段的监管文件
- 与研究者和站点工作人员沟通有关方案实施、招募、保留、方案偏离、监管文件、审计、检查和站点表现的问题
- 识别、评估并解决站点表现、质量和合规问题，并根据需要进行上报
- 与合作伙伴共同工作
查看英文原文
Job Description
**Clinical Research Associate (CRA)**
- **Permanent, full-time role** with competitive remuneration and benefits
- **Location:** Macquarie Park, Sydney, Australia - Home or office based depending on location
- **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**
**Responsibilities include, however not limited to:**
- 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 escalate 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, matrixed environment where **your expertise and judgement are valued**
- **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.
**Required Skills:**
Accountability, Adaptability, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Analysis, Data Documentation, Data Reporting, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
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**Search Firm Representatives Please Read Carefully**
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:**
25%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
10/10/2026
***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.**