Clinical Research Associate (CRA) - Immunology (Remote)

Merck; Phoenix (AZ); Remote; USD 96,000 - 151,000; Full time

Job summary

Merck is seeking a Clinical Research Associate/Monitor in the USA with responsibility for performance and compliance across assigned protocols and sites. You will ensure adherence to ICH-GCP and country regulations, manage site visits, and coordinate with cross-functional teams to maintain data integrity and patient safety.

The role requires strong site management, monitoring expertise, and the ability to travel approximately 75% of the time.

Qualifications

• Associate's degree or equivalent with at least 5 years of relevant healthcare experience, including direct site monitoring.
• Bachelor’s degree with at least 2 years of direct site management (monitoring) experience in bio/pharma/CRO.
• Immunology experience preferred.

Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and related documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages tasks with sponsor roles to achieve Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight using various tools to ensure data quality and patient safety.

Skills

Site Management

Monitoring

ICH-GCP & GCP

Regulatory Compliance

Education

Associate's degree or equivalent

Bachelor's degree

Job description

Job Description

Candidates located in the Southwest, Northwest, & Rocky Mountain (WA, OR, CA, AZ, CO, UT, ID, NM, or MT) 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.

#eligibleforERP

#clinicaltrialjobs

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

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)

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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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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

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

Primary Location:

USA - New Jersey - Rahway

Salary Range for Primary Location:

$96,200.00 - $151,400.00

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 .