Вакансія Clinical Research Associate II

We are currently looking for a knowledgeable, entrepreneurial and innovative Clinical Research Associate II to join our Clinical Operations team in Ukraine, Kyiv.

If you are ready to work with full-scale complex trials in multiple therapeutic areas, ensure high quality standards of assigned projects and effective site performance provide us with your expertise and guidance, and be involved in something new, outstanding and challenging, this job opportunity is perfect for you!

The scope of responsibilities will include:

• Conduct, and reporting of site selection, initiation, routine and closeout monitoring visits
• Site management, general administration of projects in Ukraine
• Ensuring the integrity of clinical data in adherence to all applicable regulatory guidelines, company’s SOPs and project-specific operating procedures
• Contact for clinical investigators, vendors and support services in regard to study progress
• Effective communication within cross-functional teams
• Project-specific training of sites and teams
• Preparation for and attendance at company’s audits; implementation of corrective actions
• Support to Regulatory Affairs in procurement of site regulatory documents
• Facilitation of site budgets and contract negotiations
• Maintenance of study-specific documentation and automated tracking systems
• Participation in feasibility research

An ideal candidate will have:

• MD, PharmD or MSc
• 2+ years of monitoring experience is required
• Experience in Antibiotics/ Oncology/ Multiple Sclerosis trials is a plus
• Monitoring experience in Ukraine and knowledge of the local clinical research environment
• Fluent English, both spoken and written
• Team oriented with excellent communication and interpersonal skills including a positive and professional attitude to tasks and projects
• Attention to detail, organizational and time-management skills
• Demonstrated ability to multitask and work proactively in a fast-paced environment
• Good problem solving abilities, flexibility
• Ability to travel intensively, up to 80% of the time
• Demonstrated computer skills (MS Office applications)

We offer:

• PSI have set up the grounds for Clinical Trials business in Ukraine, trained and developed many great industry experts. We have been working together for more than 20 years. We offer an inspiring story of the CRO that had always remained private, kept its ownership and grew organically from a handful of countries to global presence.
• PSI is a mature company with standards and practices, but we don’t stand still. We need your skills, experience, and energy to move the business forward. You will implement new things, work in a dynamic environment, take part in interesting projects. Every day, there is a figurative Everest to climb, but isn’t it exciting?
• We are passionate about quality, project delivery and timelines - our corporate page is all about these things, if you take a look. Our clients and the most meticulous FDA inspectors agree with every single word that you read there.
• We treat our sites with care and build excellent relationships with Investigators. Have you heard that PSI ranked number One CRO by CenterWatch Global Site Survey?
• People matter at PSI. The company invests in the employees’ development and success, and does not compromise on their well-being and prosperity, so you will like it here. Our local management team are open to feedback, strive and inspire to create a supportive environment in which we all achieve new heights together.

Please send us a letter of application and resume (both in English)