Observational Research Specialist II

30 Apr 2021
30 May 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

Job Purpose:
Independently provide site management and support activities for Observational/ Non-interventional research study sites in accordance with relevant Standard Operating Procedures (SOPs), study-specific procedures and regulations.

Key Accountabilities:

Depending on study assignment and with support as necessary key accountabilities are:
o Primary contact for assigned sites and build positive business relationships with physicians and site staff.
o Site identification, selection and start-up activities including negotiation of site agreements and budgets.
o Demonstrate protocol expertise.
o Customization of country/site specific documentation.
o Conduct of all remote and on-site monitoring activities through all study stages.
o Proactive issue management with a focus on issue prevention.
o Identification of potential out of scope activities.
o Perform regular reviews of data according to Site Management Plan (SMP).

Regularly inform manager, ORL and PL (as needed) of status of work.
o Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices
(GPP) guidelines, local country requirements, SOPs and study specific proceduresQualifications

Excellent interpersonal, verbal and written communication skills in English (and local language as necessary).
Excellent customer focus and able to interact professionally with a client organization and study site.
Strong computer skills, familiar with MS-Office products including Excel, Word and PowerPoint, Clinical Trial

Management and EDC systems:
Thorough knowledge of Observational/ Non-interventional study research and relevant regulations including GPP.
Ability to work in a'virtual' team environment as well as work independently, seeking guidance as appropriate.
Consistently delivers work to'First Time Quality' whilst managing time effectively to meet metrics and/or team objectives.
Sound problem solving and analytical skills and able to prioritize multiple tasks and achieve study timelines.
Willing to travel locally and internationally as necessary.
Seeks opportunities to develop experience and knowledge making suggestions to enhance service delivery.

Knowledge and Experience:
Clinical Monitoring, Data Management and/or research experience with a solid understanding of Observational/ Non-interventional research methodology and terminology.

Degree in a life science, nursing qualification or other relevant experience requiredWhy 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.