JOB SUMMARY 

The Site Feasibility & Activation Manager will work closely across Innovo Research site network to identify, contact, build, and maintain relationships with study teams and sites leadership for the efficient and appropriate activation of clinical research/trials. Reporting will include accountability to the COO, Director of Clinical Operations, Administrator, PI, and others, as necessary.  You are accountable for conduct of feasibility, determining interest in potential study participation, and site activation project management. Project activities include site identification, investigator and site contracts, central IRB submissions, and any other study specific activities necessary for site activation in accordance with Good Clinical Practices (GCPs), applicable local and international regulations, and Standard Operating Procedures (SOPs).  

 

The candidate will have overall responsibilities for coordinating efforts with other study team members in order to activate qualifying sites, including:  

 

BASIC FUNCTIONS:  

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  Serve as a Sponsor point of contact for feasibility, start-up and regulatory submissions items  

  
  

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  Work with both internal and external teams to assure effective communication regarding study start-up processes, expectations, and timely completion of requisite documents  

  
  

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  Assures documents maintained are following (ICH-GCP) regulatory requirements or industry standards, and procedures set forth by Innovo Research and its Clients.  

  
  

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  Understand scope of work for all studies and help with resource forecasting in the finance system 

  
  

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  Collect and disseminate Essential Documents (ED) and Investigator Site Files (ISF) during start-up 

  
  

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  Send regulatory document packets to sites and Sponsors/CROs, follow up with sites on document completion, review regulatory documents for completeness, compile in a packet for Innovo Research retention 

  
  

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  Perform quality checks on submission documents and site essential documents 

  
  

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  Complete feasibility surveys/assessments on behalf of Innovo Research and Practice Sites 

  
  

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  Engage in feasibility meetings with perspective sponsors and CROs 

  
  

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  Complete site registration information for Sponsor/CRO investigator databases 

  
  

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  Responsible for multiple simultaneous start-up projects, and typically can work independently with minimal supervision.  

  
  

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  Review of the site informed consents and negotiate through an acceptable IRB approved document. Escalate issues regarding ICF to COO and appropriate legal reviewer. 

  
  

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  Complete study level Central IRB submissions, support sites for IRB submission, provide updates to team/Sponsor on calls and via email.  

  
  

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  Assist in processing invoices to sponsors for work completed to ensure timely cash flow 

  
  

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  Facilitate the follow-up on outstanding invoices, payment of Practice Sites, and study participant stipends 

  
  

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  Hand off studies to Site Operations once IRB approved or based on other milestones  

  
  

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  Assist with site amendments, protocol amendments, continuing review (IRB progress reports), and other tasks to support continuity of operations, if required 

  
  

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  Responsible for executing CRIO build out of Source Documents and other operational needs within CRIO (or another vendor as appliable)  

  
  

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  Manage CITI account to ensure completion of requisite training and appropriate documentation of training credentials 

  
  

 

 

 KNOWLEDGE, SKILLS & ABILITIES:  

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  Strong organization/prioritization skills for the management of multiple concurrent projects 

  
  

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  Good knowledge of clinical research process related to study start-up and medical terminology  

  
  

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  An understanding of Regulatory and Central/Local ethic submission processes  

  
  

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  Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members  

  
  

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  Excellent organizational and interpersonal skills 

  
  

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  Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities  

  
  

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  Ability to manage multiple competing priorities within various clinical trials 

  
  

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  Working knowledge of current ICH GCP guidelines and applicable regulations 

  
  

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  Excellent verbal and written communication skills required  

  
  

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  Ability to work independently, prioritize and work with a matrix team environment is essential 

  
  

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  Ability to travel periodically if needed