Job Description

Are you passionate about clinical research and eager to make a significant impact in the healthcare industry? We are looking for a dedicated Clinical Research Associate II to join our team. In this role, you will be the primary site contact throughout all phases of clinical research studies, ensuring compliance with regulations and contributing to the success of our clinical trials. If you enjoy working with data and technical information, this is the perfect opportunity for you!

As a Clinical Research Associate II, you will play a crucial role in developing and maintaining strong relationships with study sites, facilitating communication, and ensuring that our research protocols are executed effectively. You will have the chance to contribute to the continuous improvement of our clinical research processes.

Key Responsibilities

• Independently manage clinical trial sites from initiation through close-out.
• Conduct on-site monitoring visits, including SQV, SIV, Routine Monitoring, and Close-Out Visits.
• Ensure compliance with protocols, ICH-GCP, sponsor requirements, and local regulations.
• Review source documents and study data to ensure quality and patient safety.
• Identify, escalate, and resolve site-related issues and risks.
• Prepare monitoring visit reports and maintain accurate study documentation.
• Maintain inspection-ready records in CTMS, eTMF, and other clinical systems.
• Build effective relationships with investigators and site personnel.
• Partner with cross-functional teams to support study delivery and site performance.

Qualifications

• Bachelor's degree
• Experience independently conducting on-site monitoring visits at hospitals and research centers.
• Experience managing sites throughout the clinical trial lifecycle.
• Experience preparing monitoring visit reports and maintaining clinical trial documentation.
• Strong knowledge of ICH-GCP, clinical trial processes, and regulatory requirements.
• Advanced English proficiency (written and spoken).
• Strong communication, organization, and stakeholder management skills.

Preferred

• Experience in CROs and/or pharmaceutical companies.
• Experience supporting audits and inspections.
• Experience across multiple therapeutic areas and clinical trial phases.

#ClinicalTrialsBR

Required Skills:

Clinical Research, Clinical Site Monitoring, Clinical Studies, Clinical Trial Documentation, Clinical Trial Management Systems (CTMS), Clinical Trials Monitoring, Data Analysis, Data Reporting, English Language, ICH GCP Guidelines, Investor Relationship Management, Regulatory Requirements

Preferred Skills:

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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:

75%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

08/31/2026

*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.