Clinical Research Associate

Kyiv
competitive
19 Jul 2019
18 Aug 2019
19006232
Full Time
Permanent
Experienced (non-manager)

Syneos Health is looking for experienced SrCRA to join the team of our Pharma client in Ukraine.
Primary responsibilities will include:
- Act as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
- Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
- Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Participate & provides inputs on site selection and validation activities.
- Perform remote and on-site monitoring & oversight activities
- Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.

 

 

 

Requirements:
- 4-5 years of direct site monitoring experience in a pharma/CRO
- B.A./B.S. preferred with strong emphasis in science and/or biology
- Ability to travel domestically and internationally approximately 65%-75% of working time
- Fluent English as well as fluent Ukrainian and Russian

The position is offered through a contract of employment with Syneos Health, including full benefits.

We have a comprehensive benefits package and offer highly competitive remuneration.

Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.