Clinical Research Associate (CRA) - Immunology (Remote)

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

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

Merck is seeking aClinical Research Associate/Monitor to oversee site performance and study conduct across assigned sites in the United States. The role ensures adherence to ICH/GCP, sponsor SOPs, local regulations, and protocol requirements, acting as primary site contact through all trial phases.

The candidate will develop site relationships, ensure data integrity, and coordinate with cross-functional teams to achieve Site Ready status.

Qualifications

• Associate's degree or higher in a scientific/healthcare field with 5+ years in healthcare; 2+ years direct site management/monitoring.
• Bachelor’s degree with 2+ years direct site management/monitoring experience in bio/pharma/CRO.
• Immunology experience preferred.

Responsibilities

• Manage clinical study sites per ICH-GCP and protocol; ensure data accuracy and patient safety.
• Develop and maintain strong site relationships across trial phases; drive site readiness.
• Coordinate with sponsor QA, regulatory, and cross-functional teams to ensure compliance.
• Perform remote and on-site monitoring, visit reports, regulatory document collection and oversight.
• Identify and address site performance issues, escalate per CRA pathways; support audits/inspections.

Skills

Site management

Monitoring

GCP/ICH proficiency

Regulatory compliance

Data review & analytics

Communication

IT literacy (MS Office, clinical apps)

Problem solving

Education

Associate's degree or equivalent (scientific/healthcare)

Bachelor’s degree or higher (biopharma/CRO)

Tools

CTMS

eTMF

MS Office

Regulatory systems

Job description

Candidates located in the South Region 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 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 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.
• Experience in Immunology preferred.

Required Skills

• Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Customer Centricity, Document Management, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Matrix Management, On Site Management, Pharmaceutics, Protocol Adherence, Protocol Review, Regulatory Affairs Management, Regulatory Compliance, Regulatory Inspections, Relationship Building, Remote Monitoring, Site Management, Study Design, Training Team Members

Preferred Skills

• Adaptive Mindset, Immunology, Immunology Research, Immunotherapy

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.

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.

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: 10/15/2026

We are a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Salary range: $96,200.00 - $151,400.00. 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.

We encourage diversity and inclusion. 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 U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement.