Job Description

Observational Research Specialist IIprovides site management for observational/non-interventional research study sites in accordance with relevant SOPs, study specific procedures and regulations. Responsibility for protocol expertise with accountability for quality and timelines and the following site start-up activities:
◦Site identification
◦Negotiation of site agreements and budgets
◦Collection and review of regulatory documents for EC and RA submissions
◦Customization of informed consent
◦Site management.

Key Accountabilities
•Primary contact for assigned sites
•Perform site start-up activities
•Demonstrate protocol expertise
•Conduct remote visits (initiation, monitoring, termination)
•Train team members on selected tasks
•Perform regular reviews of data according to data review/monitoring guidelines (CTMS, EDC,IVRS, ISIS)
•Responsible for the completeness and quality of the in-house site specific files (in cooperation with ROA/RMA)
•Update all relevant tracking systems on an ongoing basis
•Follow-up on appropriate site related questions.

Qualifications

Skills
•Sound interpersonal, oral and written communication skills
•Strong computer skills including Clinical Trial Management Systems, Electronic records, EDC, MS-Office products such as Excel, Word and PowerPoint.
•Strong awareness of all relevant regulations, including GCP and GPP
•Ability to successfully work in a ('virtual') team environment
•Strong knowledge of observational/non-interventional study research
•Sound problem solving and analytical skills
•Strong customer focus, ability to interact professionally within a client organization and with study sites
•Willing and able to travel as required - local or international.

Education
•Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience.

Language Skills
•Fluency in written and oral in Dutch, French and English is a must.

Minimum Work Experience
•Previous clinical monitoring (on-site or remote) data management and/ or research experience with a solid understanding of observational/non-interventional research methodology and terminology.

Why Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.