Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Clinical Research Associate II or Senior CRA - Ukraine

Company: Syneos Health
Location: Ukraine
Reference: PL - 17004662
Closing Date: 29 May 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Here at Syneos Health we are currently recruiting for a “CRA II / Senior CRA” in Ukraine to join us on permanent basis. The position is part of one of our client dedicated partnerships, and can be offered office based or home based across the country. The ideal candidate will have solid experience monitoring clinical trials in Ukraine.

Requirements:

Job Details:

  • Perform site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance.  Visits may be performed on-site or remotely.
  • Review completion of proper informed consent procedures.
  • Ensure accurate data reporting via review of site source documents and medical records.
  • Interpret data to identify protocol deviations and risks to subject safety/data integrity.
  • Generate queries and manage resolutions with site personnel.
  • Perform investigational product accountability as per the protocol and Study Monitoring Plan.
  • Evaluate execution of study protocol at the site level.  Use judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicate/escalate serious issues to the project team.
  • Obtain, review, and process essential regulatory and administrative documents.  Conduct audits of essential regulatory documents to ensure completeness, accuracy, and regulatory compliance.
  • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and Study Monitoring Plan.
  • Understand project scope, budgets, and timelines; manage site-level activities / communication to ensure project objectives, deliverables and timelines are met.  Must be able to quickly adapt to changing variables to achieve goals / targets. 
  • Enter data into tracking systems as required.
  • Act as primary liaison with study site personnel.
  • Participate in the identification and selection of investigators and clinical sites.
  • Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; complete assigned training as required.
  • Provide clinical and technical support for project team as required.
  • Utilize knowledge and experience to suggest improvements and/or innovations; pursue ongoing systems improvements.
  • Provide mentoring / training to less experienced staff.  May perform Monitoring Evaluation or Quality Assessment Visits.
  • May interact with representatives of client affiliates as per project requirements.

 

Qualifications

The ideal candidate will need the following experience / skills to be considered:

  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Several years clinical research experience with prior clinical monitoring experience
  • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Must demonstrate good computer skills.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
  • A good command of the English language both verbal and written
  • Ability to travel as necessary up to 70% depending on assignment.  Overnight and occasional weekend travel may be required.

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

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.

Apply for this job: Clinical Research Associate II or Senior CRA - Ukraine

Contact Information:

Address:  Poland (Polska)
Ul. Nowogrodzka 68 02-014 Warsaw (Warszawa)

Poland
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.