Senior Clinical Research Associate - Cardiovascular (Bilingual-English/Spanish)
**工作描述** _在南佛罗里达州居住的候选人受到强烈青._ 职位负责一个国家的分配协议和地点的性能和合规性。在 CRA-管理员或 CRD 监督下，该人员确保研究行为符合 ICH/GCP 和国家法规，我们的公司政策和程序，质量标准以及内部和外部不良事件报告要求。作为临床研究的所有阶段的主要网站联系人和站点经理，承担分配的站点责任。积极发展和扩大对临床研究，寻找和开发新站点的领土。作为中小企业，参与内部会议和工作流程监测过程和系统。**责任包括但不限于：** - 在试验的所有阶段发展强大的现场关系并确保现场关系的连续性。- 按照 ICH-GCP,赞助商 SOP,当地法律与法规，协议，网站监控计划以及相关文件进行临床研究站管理/监督活动。- 深入了解研究协议及其相关程序。- 与其他赞助人角色合作协调并管理各种任务以实现现场准备。- 参与并提供对现场选择和验证活动的输入。- 使用各种工具进行远程及现场监测和监督活动，以确保：- 在现场生成的数据是完整，准确且无偏见的。- 对象权，安全与福祉受到保护。- 开展包括但不限于验证访问，启动访问，监控访问，近距离访问以及记录清晰，全面和精确的访客和非访问联系报告。- 收集，审查和监视研究开端，维护和研究近距离所需的监管文件。- 与调查人员和现场工作人员沟通有关与协议行为相关的问题，- 招聘，保留，协议偏差，监管文件，网站审计/检查以及总体站点性能。- 确定，评估和解决现场绩效，质量或合规问题，并根据需要与 CRA 管理员，CRM,TA 负责人和 CRD 合作，按定义的 CRA 升级途径进行加剧。- 在内部与 GCTO 国家运营，金融方面开展合作。
查看英文原文
**Job Description**
_Candidates who reside in **South Florida** are strongly preferred._
The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA-Manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company 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.
- 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 internally 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 strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Following the country strategy defined by CRD and CRA-Manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.
- Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.
- Could perform Quality control visits if delegated by other roles and trained appropriately.
**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.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including independent 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, also in a virtual environment.
- Experience with conducting site motivational visit designed to boost site enrollment.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action.
- Capable of mentoring junior CRAs on process/study requirements and is able to perform co-monitoring visits where appropriate.
**Behavioral Competency Expectations:**
- Effective time management, organizational and interpersonal skills, conflict management, problem solving skills.
- 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:**
- **Fluent Spanish speaking skills required.**
- Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO.
**Or**
- Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO.
#eligibleforERP
#clinicaltrialjobs
**Required Skills:**
Accountability, Accountability, Adaptability, Adverse Event Report, Clinical Data Management, Clinical Development, Clinical Research Organizations (CRO) Management, Clinical Study Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Planning, Clinical Trials Monitoring, Cultural Awareness, Customer Centricity, Customer-Focused, Decision Making, Document Management, Good Clinical Data Management Practice (GCDMP), Growth Mindset, Matrix Management, Multitasking, On Site Management, Patient Recruitment, Regulatory Inspections {+ 8 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:
[EEOC Know Your Rights](https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)
[EEOC GINA Supplement](https://www.eeoc.gov/gina-genetic-information-nondiscrimination)
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 primary location for this posting is:
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$129,000.00 - $203,100.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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).
**Additional location(s):** Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
**Additional location(s) Compensation Information:**
**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:**
10/24/2026
***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.**