Clinical Research Associate Zona Norte

Job Description

We are seeking a highly skilled Clinical Research Associate (CRA) to lead performance and compliance for assigned protocols and sites within Portugal - Zona Norte. Under the oversight of the CRA Manager you will serve as the primary site contact throughout all phases of clinical studies ensuring rigorous adherence to ICH/GCP local regulations our company policies and procedures quality standards and adverse event reporting requirements.

You will take ownership of allocated sites actively collaborate in expanding our clinical research territory by identifying and developing new sites and contribute as a subject matter expert on monitoring processes and systems across internal workstreams.

The person must live in north of Portugal (Porto).

What you will do:

• Build and sustain strong relationships with investigative sites across all trial phases.
• Perform site management and monitoring activities in compliance with ICH-GCP Sponsor SOPs local laws/regulations protocol site monitoring plans and related documents.
• Execute validation initiation monitoring and close-out visits; document clear comprehensive visit and non-visit reports in a timely manner.
• Coordinate cross-functional tasks to achieve Site Ready status.
• Identify assess and resolve site performance quality or compliance issues; escalate appropriately per the CRA escalation pathway in collaboration with CRA Manager Clinical Research Manager and Clinical Research Director.
• Act as a process Subject Matter Expert: share best practices drive continuous improvement and deliver training.

What skills you will need:

• Bachelors degree (or higher) with at least 3 years of direct site management (monitoring) in bio/pharma/CRO.
• Applicants must possess a valid drivers license.
• Fluent in English with strong written and verbal communication skills and the ability to present technical information effectively.
• Robust knowledge of clinical research trial phases ICH/GCP and local clinical research regulations and guidelines; ability to work within global country and regional frameworks.
• Proven site management expertise including independent oversight of site performance and patient recruitment.
• Hands-on knowledge of Good Documentation Practices.
• Strong IT proficiency (MS Office and clinical applications across computer tablet and mobile); adaptable to new tools.
• Ability to interpret data/metrics and take appropriate action.
• Excellent time management organization interpersonal skills conflict management and problem solving.
• Strong sense of accountability and urgency; able to prioritize and multitask in changing environments. Positive growth-oriented self-driven and professional demeanor aligned with company values.

Why Join Us

We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the worlds most challenging healthcare needs.

We are proud to be a company that embraces the value of bringing diverse talented and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

So if you are ready to please apply today.

Required Skills:

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.