Local Studies & Start up specialist - level 2

30 hours per week - fully remote working

Job Overview 

• Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. 
• May also include maintenance activities. 

Essential Functions 

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. 
• Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. 
• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. 
• Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. 
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information. 
• Review and provide feedback to management on site performance metrics. 
• Review, establish and agree on project planning and project timelines. 
• Ensure monitoring measures are in place and implement contingency plan as needed. Inform team members of completion of regulatory and contractual documents for individual sites. 
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines. 
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning. Perform quality control of documents provided by sites. 
• May have direct contact with sponsors on specific initiatives. 

Qualifications 

• Bachelor's Degree Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience. 
• 3 years clinical research experience, including 1 year experience in a leadership capacity. 
• Equivalent combination of education, training and experience. In-depth knowledge of clinical systems, procedures, and corporate standards. 
• Good negotiating and communication skills with ability to challenge, if applicable. 
• Effective communication, organizational, and interpersonal skills. 
• Ability to work independently and to effectively prioritize tasks. 
• Ability to manage multiple projects. 
• Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines. 
• Knowledge of applicable regulatory requirements, including local regulations, , SOPs and company's Corporate Standards.
•  Understanding of regulated clinical trial environment and knowledge of drug development process. 
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• English and Polish Language