Clinical Research Associate - Cardiovascular (Bilingual-English/Spanish) (Remote)

MSD; Rahway (NJ); Remote; USD 96,000 - 151,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Job summary

Merck is seeking a Clinical Research Associate to manage site relationships and oversee monitoring activities across trial phases. You will ensure regulatory compliance, maintain documentation in CTMS/eTMF, and collaborate with sponsors, Investigators, and CROs to drive site performance.

Travel is required, with frequent on-site and remote monitoring. The role emphasizes data integrity, patient safety, and adherence to studies and regulatory guidelines.

Qualifications

• Experience in clinical research site management (monitoring).
• Strong knowledge of ICH-GCP, regulatory documentation and country/local guidelines.
• Ability to liaise with Investigators, sites and CROs to ensure protocol adherence.

Responsibilities

• Develops and maintains strong site relationships through all trial phases.
• Performs site management/monitoring activities in compliance with ICH-GCP and SOPs.
• Oversees regulatory documentation for start-up, maintenance and close-out.
• Communicates issues related to protocol conduct, recruitment, and regulatory documentation.

Skills

Site management

GCP/ICH knowledge

Data analysis

Regulatory knowledge

Communication

Education

Associate degree or equivalent in scientific/healthcare

Bachelor’s degree (or above)

Tools

CTMS

eTMF

MS Office

Job description

Job Description

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 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 preferred.
• Florida, Alabama, or Georgia residence highly preferred.

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:

• Fluent Spanish speaking skills required.
• 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.

Required Skills:

• Accountability, Accountability, Adaptability, Adverse Event Reporting System, Biotechnology, Cardiology, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Cultural Awareness, Customer Centricity, Data Analysis, Data Documentation, Data Reporting, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Growth Mindset, Matrix Management, On Site Management, Pharmaceutics, Protocol Adherence {+ 10 more}

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

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

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.

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.

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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.

Benefits:

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.

Job Posting End Date:

09/30/2026*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.