临床研究专员（CRA）- 肿瘤科
Clinical Research Associate (CRA) - Oncology
**职位描述**
该职位负责所分配的方案和试验点在国家范围内的执行表现和合规性。
在CRA-Manager的监督下，确保研究实施符合ICH/GCP及国家法规、公司政策和程序、质量标准以及不良事件报告要求，内部和外部均需符合。
在整个临床研究试验的各个阶段担任主要试验点联系人和试验点经理，对分配的试验点负全责。
积极拓展临床研究区域，寻找并开发新试验点。
作为监测流程和系统的专家，参与内部会议和工作流。
**职责包括但不限于：**
- 建立稳固的试验点关系，并确保试验全过程中的关系延续性。
- 按照ICH-GCP、申办方SOP、当地法律法规、方案、试验点监测计划及相关文件的要求，执行临床试验点管理/监查活动。
- 深入理解研究方案及相关流程。
- 与其他申办方角色协作，协调和管理各项任务以实现试验点准备就绪。
- 参与试验点选择和验证活动，并提供相关意见。
- 使用各种工具执行远程和现场监查与监督活动，确保：试验点生成的数据完整、准确且无偏见，受试者的权利、安全和福祉得到保护。
- 进行试验点访问，包括但不限于验证访问、启动访问、监查访问、结题访问，并及时、清晰、全面、准确地记录访问和非访问联系报告。
- 收集、审查和监控研究启动、研究维护和研究结题所需的监管文件。
- 与研究者和试验点工作人员沟通与方案实施、招募、保留、方案偏离、监管文件、试验点审计/检查及整体试验点表现相关的问题。
- 识别、评估并解决试验点表现、质量和合规问题，并根据定义的CRA升级路径，在与CRA-Manager、CRM、TA负责人和CRD合作的情况下，按需进行升级。
- 与GCTO国家运营、财务、法规事务、药物警戒、法律和区域运营、总部职能团队合作。
查看英文原文
**Job Description**
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.
Acts 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.
Participates in internal meetings and workstreams as SME for monitoring processes and
Systems.
**Responsibilities include, but are 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 and 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.
**Extent of Travel:**
- Ability to travel domestically and internationally approximately 65%-75% of working time.
- Expected travelling ~2-3 days/week.
- Current driver’s license required.
**CORE Competency Expectations:**
- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices.
- Ability to understand and analyze data/metrics and act appropriately.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.
**Behavioral Competency Expectations:**
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- Demonstrated high level of monitoring skill with independent professional judgement.
- Able to work highly independently across multiple protocols, sites and therapy areas.
- High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
- Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships.
- Demonstrates commitment to Customer focus.
- Works with high quality and compliance mind-set.
- Positive mindset, growth mindset, capable of working independently and being self-driven.
- Demonstrates and projects professional demeanor and communication consistent with organizational policies and practices.
**Experience and Educational Requirements:**
- Associate's degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
Or
- Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
#eligibleforERP
#clinicaltrialjobs
**Required Skills:**
Accountability, Accountability, Adaptability, Administrative Policies, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Core Competencies, Data Analysis, Data Reporting, Early Clinical Development, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), IT Change Management, Oncology, Pharmacovigilance, Policy Development, Preventive Action, Protocol Adherence, Regulatory Affairs Compliance, Regulatory Compliance {+ 2 more}
**Preferred Skills:**
Current Employees apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)
Current Contingent Workers apply [HERE](https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please [click here](https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
[Learn more about your rights, including under California, Colorado and other US State Acts](https://www.msdprivacy.com/us/en/CCPA-notice/)
The salary range for this role is
$96,200.00 - $151,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at [https://jobs.merck.com/us/en/compensation-and-benefits](https://jobs.merck.com/us/en/compensation-and-benefits).
You can apply for this role through [https://jobs.merck.com/us/en](https://jobs.merck.com/us/en) (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
**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:**
75%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
Yes
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
09/17/2026
***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.**