Clinical Research Associate (CRA) - Immunology (Remote)

Merck; Boise (ID); A distancia; USD 96.000 - 151.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision insurance

401(k) retirement plan

Paid holidays and vacation

Descripción de la vacante

Merck is seeking a Clinical Research Associate to oversee site performance and ensure adherence to ICH/GCP and country regulations. The role acts as primary site contact, develops new sites, and travels extensively to manage studies across regions.

Responsibilities include monitoring, site selection input, and collaboration with sponsor roles to ensure Site Ready, while maintaining CTMS/eTMF records and regulatory documents. Strong communication and problem-solving are essential.

Formación

• Minimum 5 years in healthcare with at least 2 years in site management/monitoring.
• Associate's degree or higher in scientific/healthcare field.
• Experience with ICH-GCP and regulatory documentation is required.
• Ability to travel 65-75% domestically and internationally as needed.

Responsabilidades

• Develop strong site relationships and oversee site management through all trial phases.
• Perform remote and on-site monitoring to ensure data integrity and patient safety.
• Coordinate with sponsor roles to achieve Site Ready and monitor protocol conduct.
• Maintain regulatory documentation in CTMS/eTMF and related systems.
• Escalate site performance issues per CRA processes with oversight.

Conocimientos

Clinical Site Management

GCP Compliance

ICH/GCP Knowledge

Regulatory Knowledge

Remote Monitoring

Site Audits

Data Review

Educación

Associate's degree or equivalent

Bachelor’s degree or higher

Herramientas

CTMS

eTMF

MS Office

Descripción del empleo

Job Description

Candidates located in the Southwest or Northwest (WA, OR, CA or AZ) regions 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’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.
• 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, Adverse Event Reporting System, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Cultural Awareness, 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 {+ 1 more}

Preferred Skills

Accountability, Adaptability, 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.

As an Equal Employment Opportunity Employer

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 GINA Supplement

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

Salary Range

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

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

10/14/2026

***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

R421129