Why Syneos Health? Join a game-changing company that isreinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.
Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.
You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past.
Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-
deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
Responsible for remote monitoring and site management of Phase II-IV clinical research studies while continuing to develop a solid understanding of the drug development process, Good Clinical Practices (GCP), and relevant regulations.
Manages and oversees study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines, Standard Operating Procedures (SOPs) and Project Specific Operating Procedures.
Essential Functions : 1. Site Management
1. Site Management
specific enrolment plans.
requirements / data collection tools (e.g., Electronic Data Collection (EDC) systems, Interactive Voice / Web
Response (IVR / IWR) systems, etc.), Serious Adverse Event (SAE) reporting requirements and patientreported outcomes instruments, as applicable.
Maintains timely and effective communication among team members and site staff, through oral / written
seeks guidance to resolve more complex and routine issues.
3. Regulatory Documentation
Assures compliance with applicable regulations, and guidelines, Code of Federal Regulations (CFR),
International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs.
Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan.
Participates in TMF and audits as requested; may require guidance to respond to findings. May be responsible for submission of regulatory packages to ethics committees and / or competent authorities.
Monitors all types of Phase II-IV clinical trials; participates in all types of remote site visits as required.
5. Data Handling
6. Reporting and Tracking
requiring minimal revisions.
Reports, patient enrolment, and SAEs / Endpoints.
related issues from contact to contact
Prepares for and attends Investigator meetings; may present materials, as requested. Attends clinical monitoring
staff meetings, project team meetings, clinical committees, and clinical training sessions according to the
project communication, monitoring, and / or training plans.
BA / BS degree in science / health care field or nursing degree, or equivalent combined education and experience,
required. Nominal clinical research experience required including independent monitoring and site management
experience preferred, whether remote or on-site. Moderate understanding of clinical research fundamentals
expected. Basic understanding of SOPs, WIs, FDA, and local regulations as well as ICH GCP guidelines, required.
Strong organizational, documentation, and interpersonal skills are essential, as well as a willingness to work within a
team-oriented environment. Excellent command of written and spoken local language, English and Portuguese as well as
English required. Ability to develop excellent working relationships via oral communication and excellent phone
etiquette, required. Must be proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and
voicemail. Ability to handle multiple tasks to meet deadlines in a dynamic environment, required.