Study Start-Up Country Specialist II

Job Description:

Job Title: Study Start-Up Country Specialist II (North America)

Job Location: LOCATION

Job Overview:

The Study Start-Up Country Specialist (SSUCS) works in collaboration with project teams and in collaboration with the Study Start-up Manager to perform key study start-up tasks in their country, or countries, of expertise. These tasks may include study feasibility, facilitation of site contracts and budget negotiations between sites and CP, review of document translations, IRB submissions, and other study start up activities, as assigned by the Study Start-Up Manager or designee. The Study Start-Up Country Specialist is responsible for f the collection of essential regulatory documents from sites and preparation or review of country related submission packages in accordance with ICH, GCP and all applicable regulations, laws, guidelines and ethical standards within specific timelines and quality standards. May coach, mentor or on-board more junior Specialists.

Job Duties and Responsibilities:

• Independently provides country-level expertise and support to study start-up team and project team
• Builds relationships with sites and investigators within country of expertise
• Participates in the identification and selection of sites and investigators, including national lead investigators, as necessary.
• Responsible for distribution, collection and review of site essential documents either directly or through coordination with assigned CRAs in specific countries
• Responsible for the submission to Central IRBs and assisting sites with the submissions to Local IRBs as needed. May be assigned to the sites with complex internal processes or requiring empowerment to independent decision making
• Responsible for the collection and maintenance of the current IRB submission information, and similar information for the assigned countries.
• Provides submission strategy based on practical previous experience
• Independently responsible for review and negotiation of Country and/or Site ICFs
• Responsible for review and negotiation of site study budget
• Perform timely and accurate data entry of Study Start-Up (“SSU”) status and documents, regulatory documents and submission status of country/site information in applicable tracking system (s)
• May be assigned to coach, mentor or on-board new hires or junior Specialists
• Contributes into functional improvement initiatives
• Other duties as assigned by the SSU Manager, Study Start-Up & Regulatory Lead, Country Manager, Director of Study Start-Up, or designee per project-specific requirements
  
  

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

Education:

• Bachelor’s graduate with a healthcare or life science degree or equivalent experience
  
  

Experience:

• Minimum 3 years of experience in study start up or study regulatory position preferably in the CRO or pharma industry related to IRB submissions, document collection, Essential Document binder preparation
  
  

Skills/Competencies:

• Strong written and verbal communication skills
• Native-level or equivalent fluency with local language sufficient to translate / review / draft local language documents, if applicable
• Strong interpersonal skills
• Comprehensive knowledge of GCP/ICH guidelines
• Proficiency in medical terminology
• Able to exercise judgment within defined procedures and practices and to determine appropriate action independently
• Attention to detail
• Problem-solving skills
• Ability to work in a matrix environment
• Strong time management and organizational skills
• Fluent in English
  
  

Capabilities:

• Has demonstrated experience in SSU activities and in preparation of regulatory submission package to IRB in accordance to GCP, ICH guidelines and to country specific standards.
• Adheres to study timelines, documents study challenges, document collection and communicates updates to SSU PM and/or SSU Manager.
• Proficient computer skills, including Microsoft Office.