Compliance ofertas em Alemanha

Job Description

Join Our Team as a Clinical Research Associate III!

Are you passionate about clinical research and eager to make a positive impact on healthcare? We are looking for a dedicated Clinical Research Associate III to join our team! In this role, you will be the primary site contact throughout all phases of clinical research studies, with responsibility for allocated sites.

Main responsibilities include, but are not limited to:

• Act as the primary site contact and manager throughout all phases of clinical research studies, taking overall responsibility for allocated sites.
• Develop and expand the territory for clinical research by finding and developing new sites.
• Perform clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor Standard Operating Procedures (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 input as needed.
• Conduct remote and on-site monitoring to ensure data integrity and the protection of subjects’ rights, safety, and well-being.
• Conduct site visits, including validation, initiation, monitoring, and close-out visits, documenting findings accurately and in a timely manner.
• Collect, review, and monitor required regulatory documentation throughout study start-up, maintenance, and close-out phases.
• Communicate effectively with investigators and site staff regarding protocol conduct, recruitment, retention, and overall site performance.
• Identify, assess, and resolve site performance or compliance issues, escalating as appropriate.
• Collaborate internally with various departments and externally with vendors, Institutional Review Boards (IRB)/Independent Ethics Committees (IEC), and regulatory authorities 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) to share best practices and provide training as required.
• Support and/or lead audit and inspection activities as needed.
• Mentor junior Clinical Research Associates (CRAs) on process and study requirements, performing co-monitoring visits where appropriate.

Main Requirements:

• Education: Bachelor’s degree required, with emphasis in life sciences, biology, or related fields.
• Experience: Solid 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 (GCP) & 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.
• Ability to work effectively in a matrix multicultural environment.

If you are ready to take the next step in your career and contribute to impactful clinical research, apply now and join us in making a difference!

ClinicalTrialsBR

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:

75%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

Yes

Hazardous Material(s):

n/a

Required Skills:

Adverse Event Report, Adverse Event Report, Clinical Data Management, Clinical Development, Clinical Medicine, Clinical Research, Clinical Research Organizations (CRO) Management, Clinical Site Management, Clinical Studies, Clinical Study Management, Clinical Study Protocols, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trial Management Systems (CTMS), Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, CO Monitoring, Electronic Trial Master File, Good Clinical Data Management Practice (GCDMP), Good Clinical Practice (GCP), ICH GCP Guidelines, Maintenance Processes, On Site Monitoring {+ 2 more}

Preferred Skills:

Job Posting End Date:

05/20/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R349152