Clinical Research Associate II

Job Description

Clinical Research Associate II

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 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.

Main Responsibilities Include, but Are Not Limited To:

• Develop and maintain strong relationships with study sites throughout all phases of clinical trials.

• Ensure compliance with International Council for Harmonisation/Good Clinical Practice (ICH-GCP), local regulations, and company policies during site management and monitoring activities.

• Gain a comprehensive understanding of study protocols and related procedures.

• Coordinate tasks with other sponsor roles to achieve "Site Ready" status and participate in site selection and validation activities.

• Conduct remote and on-site monitoring to ensure data integrity and subject safety.

• Document findings accurately during site visits, including initiation, monitoring, and close-out visits.

• Collect and review regulatory documentation throughout study phases.

• Communicate effectively with investigators and site staff regarding protocol conduct and site performance.

• Identify and resolve site performance or compliance issues, escalating as necessary.

• Manage information in Clinical Trial Management Systems (CTMS) and electronic Trial Master Files (eTMF).

• Act as a Subject Matter Expert (SME) to share best practices and provide training.

• Support audit and inspection activities as needed.

Main Requirements:

• Bachelor's degree

• Solid experience as a Clinical Research Associate, preferably in a similar role.

• Fluent in local languages and advanced proficiency in English (verbal and written).

• Strong understanding of clinical research processes, phases of clinical trials, and ICH-GCP guidelines.

• Excellent communication skills, with the ability to present technical information effectively.

• Proven skills in site management and patient recruitment.

• Strong analytical skills to understand and act on data and metrics.

• Proficiency in MS Office and clinical IT applications.

• Ability to work independently and manage multiple tasks in a fast-paced environment.

#ClinicalTrialsBR

Required Skills:

Accountability, Accountability, Adaptability, Adverse Event Reporting System, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Data Analysis, Data Reporting, Early Clinical Development, FINRA Regulations, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), Internal Audit Controls, Investigation Procedures, IS Audit, Maintenance Processes, Medical Research, Pharmaceutical Regulatory Affairs, Pharmacy Laws, Process Consulting, Protocol Adherence {+ 4 more}

Preferred Skills:

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/21/2026

*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.

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