About The Position
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Requirements
- Bachelor's degree in a related field
- Minimum of 5 years of experience in clinical research monitoring; this role is a progression within the level from a Sr CRA I
- 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
- Strong scientific background
- Strong experience in Cell & Gene Therapy
- Proficiency in clinical trial management systems and software
- Ability to manage multiple projects and priorities
- Strong attention to detail and organizational skills
- Ability to travel as required for on-site monitoring
- Knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
Nice To Haves
- Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Responsibilities
- Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, case report forms, and regulatory documents
- Develop tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and standard operating procedures
- Contribute to the design, implementation, and delivery of processes, programs, and policies by providing expert input and feedback during development and review stages
- Direct the work of lower-level professionals or manage processes and programs, including training and mentoring junior staff and overseeing their monitoring activities
- Ensure trials are conducted in accordance with regulatory requirements and company standards by performing regular audits and inspections, and addressing any compliance issues that arise
- Provide guidance and support to clinical research teams, including answering questions, resolving issues, and facilitating communication between team members and stakeholders
- Maintain accurate and timely documentation of monitoring activities, including writing detailed monitoring reports, tracking study progress, and updating databases
- Identify and resolve issues related to clinical trial conduct, such as protocol deviations, data discrepancies, and adverse events, and implement corrective and preventive actions as needed
- Collaborate with cross-functional teams to ensure successful trial execution, including working with project managers, data managers, biostatisticians, and regulatory affairs specialists
Benefits
- a company car or car allowance
- Health benefits to include Medical, Dental and Vision
- Company match 401k
- eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
