Clinical Research Associate (CRA) - Neurology (Remote)

Praxy

Rahway, Northern (NJ, KY)

Hybrid

USD 96,000 - 151,000

Full time

41 hours ago
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Benefits offered by this job

Medical insurance
Dental insurance
Vision care
401(k) retirement plan
Paid holidays
Vacation days
Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Clinical Research Associate (CRA) focused on Neurology to manage sites and monitoring activities across trial phases. The role requires strong ICH-GCP knowledge and cross-functional collaboration with sponsor teams.

The CRA will travel domestically up to 75% of the time, and will support regulatory documentation, site selection, and quality oversight in a fast-paced, matrix environment.

Qualifications

  • Strong knowledge of ICH-GCP and country regulations.
  • Experience in site management and monitoring.
  • Proven ability to manage regulatory documentation and CTMS/eTMF knowledge.

Responsibilities

  • Develops strong site relationships across phases of trials.
  • Performs remote and on-site monitoring per SOPs and protocol.
  • Ensures data integrity and subject safety through monitoring.
  • Manages regulatory documentation for start-up, maintenance and close-out.
  • Communicates with Investigators and site staff on protocol issues.
  • Supports audit/inspection activities as needed.

Skills

Clinical Site Management
Clinical Study Management
Clinical Trials Monitoring
Data Reporting
GCDMP
Neurology
Relationship Building
Remote Monitoring
Site Management

Education

Associate's degree or equivalent
Bachelor’s degree or above

Job description

# Clinical Research Associate (CRA) - Neurology: USA - New Jersey - Rahway: Oct 8, 2026: Oct 9, 2026## About the roleJob DescriptionCandidates located in the Southeast region (GA, FL, AL, MS, LA) 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 andSystems.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.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 Neurology preferred.#clinicaltrialjobs#eligibleforERPRequired Skills:Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring, Data Reporting, Good Clinical Data Management Practice (GCDMP), Neurology, Relationship Building, Remote Monitoring, Site ManagementPreferred Skills:Clinical Trials, Neurological Disorders, On Site MonitoringCurrent Employees apply HERECurrent Contingent Workers apply HEREUS 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 if you need an accommodation during the application or hiring process.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 RightsEEOC GINA SupplementWe 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 ActsThe salary range for this role is$96,200.00 - $151,400.00This 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 https://jobs.merck.com/us/en/compensation-and-benefits.You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:75%Flexible Work Arrangements:RemoteShift:Not IndicatedValid Driving License:YesHazardous Material(s):n/aJob Posting End Date:10/22/2026
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