Syneos Health

CRA II / Sr CRA in Oncology Team (Hungary)

Location
Home Based, HUN
Salary
Competitive
Posted
15 Apr 2021
Closes
05 May 2021
Ref
21003469
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Clinical Research Associate II

Oncology studies

Permanent contract

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
  • Identifies, evaluates, and recommends potential investigators/sites on an on-going to assist in the placement of planned clinical studies with qualified investigators.
  • Critically reviews and analyzes site activities through frequent visits and contacts to monitor study sites following the monitoring plan and applicable Client SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
  • Ensures quality of data submitted from study sites and assures timely submission of data.
  • Ensures safety and protection of study subjects according to the monitoring plan, Client SOPs, and ICH and/or FDA GCP Guidelines.
  • Supervises overall activities of site personnel over whom there is no direct authority and motivates /influences them to meet study objectives.
  • Anticipates and proactively solves study site problems/issues as they occur. Initiates, recommends and communicates corrective actions as needed.
  • Ensures documented follow-up to all outstanding issues, within the scope of this position profile.
  • Appropriately escalates serious or outstanding issues to line manager and project team members.
  • Proactively communicates and escalates with all internal and external stakeholders any issues identified at study sites while developing the corresponding mitigation strategies and recommended approach.
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
What we're looking for
  • Minimum 2 years of independent monitoring experience
  • Experience in monitoring Onoclogy studies required
  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills
  • Ability to manage required travel of up to 50% on a regular basis


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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