Site Access Specialist – Australia or New Zealand

  • Company:
    Syneos Health
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    21 hours ago
  • Category:

DescriptionSite Access SpecialistCome discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of. As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors. Why Syneos Health• #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference. • We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. Job responsibilities• Acts as primary contact to the Site Access Lead in an assigned country/region for awarded or ongoing trials. May also act as primary contact to pre-award team for blinded site level feasibility performed in response to a Request for Proposal.• Utilizes local knowledge and relationships to contribute to the local country and site plan for the study (number of sites proposed, type of sites, recruitment rates, competitive studies and key challenges). Validates feasibility/site ID assessment during the study and supports the preparation of the final feasibility report by collecting feasibility data from potential sites. • Acts as primary contact to the investigational sites and study staff to collect and QC data from feasibility surveys, includes the tracking and documentation of such activities into the Syneos Health Investigator database and interaction with internal study team members as required.• Builds local relationships with key research sites and Key Opinion Leaders.• Leads the collection and review of country specific historical site/investigator experience data and data entry in to a centralized Syneos Health Investigator database. Performs searches of external data sources to identify additional investigators to build the database.• Performs review of regulatory sources to determine if regulatory actions exist against investigators. Documents and shares any findings with the study team. Conducts validation and verification checks of site/investigator contact details for the purposes of finalizing a Site/Investigator list for a planned study.• Distributes and collects privacy notice and consent forms, confidentiality agreements, feasibility questionnaires, and other site access documents (e.g. protocol synopsis) to potential study sites. Liaise with representatives from Legal during site confidentiality agreement negotiations.• Supports Site Access Lead (SAL) with preparation and documentation of corrective and preventive actions associated with quality issues. Communicates compliance and performance to relevant stakeholders as appropriate.• Ensures submission of site access related documents to the dedicated project file in the collaborative workspace and manages Study Specific folders in accordance with the corporate and departmental processes.• Contributes to the development and maintenance of site access related internal tools and processes.• Serves as back-up for colleagues, when required.QualificationsWhat we’re looking for• BA/BS in the biological sciences or related discipline in the natural sciences/health care field (e.g. RN• Experience in the clinical research field and/or patient recruitment experience• Experience working in a pharmaceutical, biotech, contract research organization or clinical research site preferred • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, database applications), email, and internet• Strong presentation skills, interpersonal skills, as well as a team oriented approach. • Excellent verbal, written, communication and time management skills• Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work • Ability to be flexible, adapt to change, work independently, as well as work as part of a team in a matrix environment. Bilingual skills preferred Get to know Syneos HealthWe are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. 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.Primary Location:Asia Pacific – AUS-Sydney-924-Pacific-HwyOther Locations:Asia Pacific – AUS-Adelaide-159-Port-Road, Asia Pacific – NZL-Home-Based, Asia Pacific – AUS-Home-BasedJob:Site OperationsSchedule:Full-timeTravel:NoEmployee Status:Regular