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

Merck; Baton Rouge (LA); Remote; USD 90,000 - 140,000; Full time

Job summary

Merck & Co., Inc. seeks a Clinical Research Associate to oversee performance and compliance for assigned protocols and sites in the United States.

Under CRA-Manager oversight, ensure study conduct aligns with ICH/GCP, country regulations, and internal policies while maintaining strong site relationships and regulatory documentation. The role involves site monitoring, input on site selection, and collaboration across sponsor functions, with substantial travel required (≈65–75%).

Qualifications

• Fluent in Spanish or other local languages as applicable
• Relevant healthcare/science education with 5+ years in healthcare
• Direct site management (monitoring) experience in biotech/pharma/CRO preferred

Responsibilities

• Develops strong site relationships and maintains them through all trial phases.
• Performs site management/monitoring per ICH-GCP, Sponsor SOPs, local laws, and monitoring plan.
• Gains in-depth understanding of the study protocol and procedures.
• Coordinates with sponsor roles to achieve Site Ready.
• Participates in site selection and validation activities.
• Performs remote and on-site monitoring to ensure data quality and patient safety.
• Collects and reviews regulatory documentation for study start-up and close-out.
• Communicates with investigators about protocol conduct, recruitment, and audits.
• Identifies and resolves site performance or compliance issues with escalation as needed.

Skills

Site Management

GCP/ICH

Data Analysis

Regulatory Documentation

Cross-functional Collaboration

Monitoring Visits

Problem Solving

MS Office

Education

Associate's degree or certificate in scientific/healthcare

Bachelor’s degree or higher

Tools

CTMS

eTMF

Job description

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 (https://go.msd.com/~vs4xix) 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 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.

#eligibleforERP

#clinicaltrialjobs

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}

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.

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:

10/12/2026

***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.

Requisition ID: R418710