Job Description

Join Our Team as a Clinical Research Associate II!

Are you an experienced clinical research professional ready to take the next step in your career? We are seeking a Clinical Research Associate II to join our team. In this advanced role, you will develop strong site relationships and be responsible for effective site management throughout all phases of clinical research trials.

Key Responsibilities:

Develop and maintain strong relationships with study sites to ensure continuity and success throughout the trial phases.Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, local laws, and regulations.Gain an in-depth understanding of study protocols and related procedures.Coordinate and manage various tasks in collaboration with other sponsor roles to achieve “Site Ready” status.Participate in site selection and validation activities, providing valuable input.Conduct remote and on-site monitoring and oversight activities to ensure data integrity and the protection of subjects’ rights, safety, and well-being.Conduct comprehensive site visits, including initiation, monitoring, and close-out visits, and document findings accurately and timely.Collect, review, and manage required regulatory documentation for study start-up, maintenance, and close-out phases.Communicate effectively with investigators and site staff regarding protocol conduct, recruitment, retention, protocol deviations, and overall site performance.Identify, assess, and resolve site performance, quality, or compliance issues in collaboration with stakeholders.Work in partnership with internal and external teams to support assigned sites.Manage and maintain information in Clinical Trial Management Systems (CTMS), electronic Trial Master Files (eTMF), and other relevant systems.Act as a Subject Matter Expert (SME) within the CRA team, mentoring colleagues and sharing best practices.Support and/or lead audit and inspection activities as required.Perform co-monitoring visits when appropriate.Contribute to the identification of new potential sites and assist in developing their clinical research capabilities.

Main Requirements:

Education: Bachelors degree required, with emphasis in life sciences, biology, or related fields.Experience: Previous experience in the role of Clinical Research Associate is essential.Languages: Fluent in Portuguese and possess advanced English (verbal and written).Understanding of clinical research processes, phases of clinical trials, and current ICH Good Clinical Practice & country-specific clinical research laws and guidelines.Hands-on knowledge of Good Documentation Practices.Developing skills in site management, including performance management and patient recruitment.Strong monitoring skills complemented by independent professional judgment.Ability to perform root cause analysis and implement preventive and corrective actions.Work Environment: Ability to work effectively in a matrix multicultural environment.

Are you ready to advance your career and play a crucial role in enhancing clinical research? Apply now and become a vital part of our mission to improve healthcare!

ClinicalTrialsBR

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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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Administrative Policies, Adverse Event Report, Clinical Evaluation Reports, Clinical IT, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Testing, Clinical Trials Analysis, Data Management, Early Clinical Development, Electronic Data Capture (EDC), Good Clinical Data Management Practice (GCDMP), Human Resources Policies, Investigations Training, Medical Research, Patient Recruitment, Performance Monitoring, Pharmacovigilance, Policy Development, Quality Mindset, Recruiting, Regulatory Affairs Compliance {+ 2 more}

 Preferred Skills:

Job Posting End Date:

07/24/2025

*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.

Requisition ID:R355564