Job Description
We are seeking a highly motivated Clinical Research Associate II (CRA II) to join our Clinical Development team. In this role, you will be accountable for the performance and compliance of assigned protocols and sites within the country, ensuring that all study activities are conducted in accordance with ICH/GCP, applicable country regulations, and company policies and procedures.
Under the oversight of the CRA Manager, the CRA II serves as the primary site contact and site manager throughout all phases of the clinical research study, taking overall responsibility for allocated sites. This role also plays an important part in expanding the clinical research territory by identifying and developing new sites, while contributing as a subject matter expert for monitoring processes and systems within internal workstreams.
Key Responsibilities:
- Build and maintain strong site relationships to ensure continuity throughout all phases of the trial.
- Conduct site management and monitoring activities in compliance with:ICH-GCPSponsor SOPslocal laws and regulationsprotocol requirementssite monitoring plan and related documents
- Develop a deep understanding of the study protocol and related procedures.
- Coordinate and manage tasks with cross-functional sponsor teams to achieve site readiness.
- Participate in site selection and validation activities and provide input as needed.
- Perform remote and on-site monitoring and oversight to ensure:data collected are complete, accurate, and unbiasedsubject rights, safety, and well-being are protected
- Conduct validation, initiation, monitoring, and close-out visits, and prepare accurate and timely visit and non-visit contact reports.
- Collect, review, and monitor essential regulatory documentation for study start-up, maintenance, and close-out.
- Communicate effectively with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audit/inspection readiness, and site performance.
- Identify, assess, and resolve site quality, performance, or compliance issues, and escalate appropriately in collaboration with the CRA Manager and other relevant stakeholders.
- Partner with country operations, finance, regulatory affairs, pharmacovigilance, legal, regional operations, HQ functions, vendors, IRBs/IECs, and regulatory authorities to support assigned sites.
- Maintain accurate and timely documentation in CTMS, eTMF, and other applicable systems.
- Contribute to team capability by serving as a process SME, buddy, or mentor and sharing best practices.
- Support and/or lead audit and inspection activities as required.
- Perform co-monitoring visits where appropriate.
- Contribute to the identification and development of new clinical research sites in line with country strategy.
- Help build strong clinical research capabilities at new and emerging sites.
Travel Requirement:
This position requires approximately 65%–75% travel, typically 2–3 days per week, with both domestic and international travel as needed. A current driver’s license is preferred.
Qualifications, Skills, and Experience:
- Fluency in local language(s) and English, both written and spoken, with excellent communication skills and the ability to explain technical information clearly.
- Strong knowledge of clinical research, clinical trial phases, GCP/ICH guidelines, and applicable country regulations.
- Good understanding of global and regional clinical research requirements and the ability to work within them.
- Hands-on knowledge of Good Documentation Practices.
- Proven site management experience, including site performance and patient recruitment.
- Strong monitoring skills with the ability to exercise independent professional judgment.
- Proficiency in MS Office and other clinical IT systems, with the ability to adapt quickly to new technologies.
- Ability to interpret and analyze data and metrics and take appropriate action.
- Ability to assess complex issues, work in a solution-oriented manner, and implement root cause analysis, corrective actions, and preventive actions.
Behavioral Competencies:
- Strong time management, organizational, interpersonal, conflict management, and problem-solving skills.
- Ability to work independently across multiple protocols, sites, and therapeutic areas.
- High sense of accountability and urgency, with the ability to prioritize and manage multiple tasks in a changing environment.
- Effective collaboration in a matrix, multicultural environment with culturally sensitive working relationships.
- Strong customer focus and commitment to quality and compliance.
- Positive, self-driven, and growth-oriented mindset.
- Professional demeanor and communication aligned with organizational policies and practices.
Education and Experience:
One of the following is required:
- Associate’s degree, certificate, or equivalent in a scientific or healthcare discipline, plus at least 5 years of relevant experience in healthcare, including at least 2 years of direct site management/monitoring experience in a bio/pharma/CRO environment; or
- Bachelor’s degree or higher, plus at least 2 years of direct site management/monitoring experience in a bio/pharma/CRO environment.
Why Join Us?
This is an excellent opportunity for an experienced clinical research professional who thrives in a dynamic, high-quality, and compliance-driven environment. If you are passionate about site management, collaboration, and advancing clinical research, we invite you to apply.
Additional location(s) Compensation Information:
Required Skills:
Clinical Reporting, Clinical Research, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials Monitoring
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
50%
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
Yes
Hazardous Material(s):
n/a
Job Posting End Date:
12/5/2026
*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.
