CLINICAL TRIAL SPECIALIST II

 ***MUST HAVE STRONG SITE STUDY START-UPS***

• Perform Study Start-up Tasks
• Take responsibility for specific tasks on projects, or acts as the main CTS contact on individual projects
• Train team members on selected tasks
• Mentor and train new staff as appropriate
• Action site selection strategy
• Refine project-specific site selection strategy at a country level
• Identify new potential Investigators and enter/update clean information into the tracking systems
• Ensure feasibility, review and approval of site identification list coming from IISS
• Conduct country specific feasibility and/or site pre-qualification and/or site selection activities (except for qualification visits, which will be done by CRAs)
• Create country specific / site specific (if necessary) Informed Consent Form (ICF)
• Review and approve country specific ICFs (if necessary)
• Prepare and negotiate clinical site agreement on a country level
• Prepare and submit Institutional Review Board (IRB)/Ethics Committee (EC) applications until final approval received (initial submission / Amendments)
• Customize SRP Guidelines
• Collect and compile regulatory documents in collaborations with the CRA and CMA
• Review and approve SRP
• Immediately update tracking system once regulatory documents are approved
• Adapt drug label for country requirements in cooperation with Regulatory and the Logistics Team (if applicable)
• Organize translations per country/regulatory/client requirements
•  Submit safety updates to IRB/IEC (if applicable)
• Prepare and submit MOH/RA documentation and follow-up until final approval received (Initial submission/Amendments), where applicable in countries fulfilling responsibilities of regulatory services
• Assist with QC/audit of central files and liaise with Quality Assurance personnel as required
• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
• Strong regulatory knowledge including GCP and local laws
• Excellent interpersonal, verbal and written communication skills
• Ability to successfully work in a virtual team environment
• Client focused approach to work with the ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Able to take initiative and work independently
• Sense of urgency in completing assigned tasks
• Effective time management in order to meet daily metrics or team objectives

Experience:

• Strong computer and internet skills including knowledge of MS-Office products such as Excel, Word
• Strong regulatory knowledge including GCP and local laws
• Excellent interpersonal, verbal and written communication skills
• Sound problem solving skills
• Ability to successfully work in a virtual team environment
• Client focused approach to work with the ability to interact professionally within a client organization
• Ability to prioritize multiple tasks and achieve project timelines
• Able to take initiative and work independently
• Sense of urgency in completing assigned tasks
• Effective time management in order to meet daily metrics or team objectives
• Shows commitment to and performs consistently high quality work
• Flexibility towards work assignments

TO APPLY: Please email Ginger Mauk at gmauk@greenkeyllc.com. Please indicate "CTS II" on the subject heading of your email.