Syneos Health

SSU Regulatory Coordinator (with English AND German, French, Polish, Russian)

Location
Serbia, Serbia
Salary
Competitive
Posted
27 Jul 2021
Closes
20 Aug 2021
Ref
21008229
Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Site Start-Up Regulatory Coordinator

Come 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
• Provide support with site selection lead and Project Manager (PM)/SSU Leadership (SSUL) to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• Assists in administration of contract management and essential document processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project, country and site level.
• Assists with quality control processes and translation processes related to submissions, contracts and essential documents.
• Under supervision may assist in negotiations of budget and contracts with site and via Site Contracts Service Center and SSUL with Sponsor until resolution of issues.
• Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Assists SSU staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• May serve as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary.
• Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Provides support in preparation of Ethics Committee, Regulatory and any other relevant local applications and submissions.
• May assist in ensuring compliance within the forecasted country/site timelines, helping to ensure compliance with milestone progress in agreed upon SSU tracking system in real time.
• Facilitates the execution of contracts by company signatories.
• Supports the maintenance of contract and essential document templates and site-specific files and databases.
• Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
• Reviews and complies with SOPs and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.What we're looking for
• Associate's Degree or equivalent combination of education and training preferred.
• Fluency in English and one of the following languages: Polish, German, French or Russian.
• Ability to interact effectively and appropriately with investigative site personnel and internal stakeholders.
• Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
• Ability to take direction from multiple individuals and set priorities accordingly.
• Ability to effectively communicate across multiple function groups (Clinical team, PM, Director).
• Demonstrated ability to work independently, as well as part of a team.
• Utilize problem-solving techniques effectively.
• Quality-driven in all managed activities.
• Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.
• Business level of proficiency in written and spoken English language.

Get to know Syneos Health
We 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.

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