Observation Research Specialist II

at  Parexel

KEY ACCOUNTABILITIES:

• Depending on study assignment and with support as necessary key accountabilities can include:
• Primary contact for assigned sites and build positive business relationships with physicians and site staff.
• Site identification, selection and start-up activities including negotiation of site agreements and budgets.
• Customization of country/site specific documentation.
• Conduct of all remote and on-site monitoring activities through all study stages.
• Identification of potential out of scope activities.
• Perform regular reviews of data according to Site Management Plan (SMP).
• Responsible for the completeness and quality of the site files for the assigned sites.
• Maintain study management system(s) on a daily basis.
• Maintain a working knowledge and ensure compliance with applicable Good Pharmacoepidemiology Practices (GPP) guidelines, local country requirements, SOPs and study specific procedures.
• Contribution to department service delivery and participation in initiatives.

Knowledge and Experience:

• Strong experience with Observational/ Non-interventional research studies.
• Able to manage study from FEAS to Close out (including Ethics Committee submission and CSA negotiation)

EDUCATION:

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

SKILLS:

• Excellent interpersonal, verbal and written communication skills.
• 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.
• Ability to manage complex workload (across multiple studies as necessary) and prioritize accordingly.
• 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 internationally as necessary.
• Effectively applies knowledge to provide advice or solutions based on expertise and experience.

Please refer the Job description for details