Sr CRA II

Sr CRA II - Sponsor dedicated - Brazil Home Based

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone belongs.

Job Responsibilities

• Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including verifying the accuracy and completeness of data and adherence to study protocols.
• Develop and implement tools, procedures, and processes to ensure quality monitoring, including standardized templates for monitoring reports and site visit checklists.
• Contribute to the design, implementation, and delivery of processes, programs, and policies, including participation in development of clinical trial protocols and input on study design and methodology.
• Manage and direct the work of lower-level professionals or manage processes and programs, including providing guidance to junior staff and overseeing day-to-day activities of clinical trial sites.
• Ensure accurate and timely documentation and reporting of clinical trial data, including maintaining site visit records and preparing reports for regulatory submissions.
• Collaborate with cross-functional teams (data management, biostatistics, regulatory affairs) to support successful execution of clinical trials.
• Identify and resolve issues related to clinical trial conduct and data integrity, including troubleshooting data collection problems and addressing discrepancies.
• Provide training and mentorship to junior staff, including conducting training sessions on monitoring techniques and best practices.

Qualifications

• Bachelor's degree in a related field
• Minimum of 3-5 years of experience in clinical research or a related field
• In-depth knowledge of clinical trial processes and regulations
• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team

Certifications

• Certified Clinical Research Professional (CCRP) or equivalent certification preferred

Necessary Skills

• Proficiency in clinical trial management systems and software
• Strong organizational and time management skills
• Attention to detail and accuracy
• Ability to manage multiple projects and priorities simultaneously
• Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Summary

Roles within Clinical Monitoring/CRA job family at the P22 level are responsible for monitoring clinical research studies to ensure that trials are conducted in accordance with widely accepted clinical practices. This includes conducting on-site and remote monitoring, developing tools, procedures, and processes to ensure quality monitoring. These roles involve individual contributors with responsibility in a professional or technical discipline or specialty, who may manage two or fewer employees and direct the work of lower-level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation, or delivery of processes, programs, and policies. These roles have a significant impact on the success of clinical research studies, ensuring data quality and compliance with SOPs, ICH-GCP, and regulatory requirements. They may provide audit readiness guidance and mentorship to site personnel and, at times, assume clinical functional leadership tasks.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research, Analyst, and Information Technology

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