Site Activation Specialist II / Start-Up CRA

Site Activation Specialist II / Start-Up CRA

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. 

Job Responsibilities

• Manage and execute the site identification process in accordance with regulations, SOPs, and project requirements, ensuring timely and accurate completion of all tasks
• Complete and negotiate site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, ensuring compliance with legal and regulatory requirements
• Maintain, review, and report on site performance metrics, identifying areas for improvement and implementing corrective actions as needed
• Serve as the primary point of contact for investigative sites, providing support and guidance throughout the site identification process
• Track the completion of site identification for sites, ensuring all necessary documentation is collected and maintained in accordance with SOPs and project requirements
• Contribute to the design, implementation, and delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education and experience
• Utilize practical knowledge of the professional area to manage defined components of projects or processes within area of responsibility, ensuring alignment with overall project goals and objectives
• Direct the work of lower level professionals or manage processes and programs, providing guidance and support to ensure successful completion of tasks
• Collaborate with cross-functional teams to ensure seamless integration of site identification activities with other project components
• Stay current with industry trends and best practices, incorporating new knowledge and skills into daily work to enhance overall performance
• Qualification visits for Phase I - III studies

Qualifications:

• Bachelor's degree in a relevant field or equivalent experience
• Minimum of 3 years of experience in site start-up or site identification
• Fluency in German
• Strong understanding of regulations, SOPs, and project requirements related to site identification
• Excellent negotiation and communication skills
• Ability to manage multiple tasks and projects simultaneously
• Detail-oriented with strong organizational skills\
• Flexibility to do site qualification visits
• Submission experience in EU-CTR and Switzerland.
• Experience as Manager/CRA or on this account preferred

Certifications:

• Certification in clinical research or related field preferred
• Training in Good Clinical Practice (GCP) and other relevant regulations

Necessary Skills:

• Proficiency in site confidentiality agreements (CDAs) and site information forms (SIFs)
• Ability to maintain, review, and report on site performance metrics
• Strong problem-solving and analytical skills
• Effective communication and interpersonal skills
• Ability to work independently and as part of a team
• Proficiency in relevant software and tools

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.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.