Clinical Research Associate; Portuguese Fluency

Position: Clinical Research Associate (Portuguese Fluency)
Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Research Associate (Portuguese Fluency) for a Contract assignment with one of our premier Healthcare clients in Boston, MA.

* 70% will be traveling to and from sites and 30% will be completed remote at home
* Responsibilities :

• Ability to prioritize workload and manage multiple protocols
• Contribute to the identification of new sites for clinical trials
• Implement complete site management including monitoring visits and regulatory assessment
• Resolve technical and content issues to achieve timely database lock targets
• Negotiate investigator remuneration and prepare financial contracts
• Implement site close-out activities and generate site close-out report
• Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff;
• Responsible for medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements;

Required Skills:

• Must be fluent in Portuguese
• Bachelor's Degree
• Must have 3+ years experience as a CRA from either a pharmaceutical or CRO background
• Minimum 3 years prior monitoring experience with global trials
• Minimum 2 years experience with direct interim monitoring experience including SDV (Source Document Verification), SDR (Source Data Review) and MRR (Medical Record Review)
• Must have an In-depth knowledge of FDA regulations and ICH/GCP guidelines
• Must be familiar and adept with managing fully decentralized studies

Preferred Skills:

• CCRA or SOCRA certified - highly preferred

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SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do.

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