Feasibility Specialist

FS
  • Remote
  • Permanent

The Feasibility Specialist plays an important role in assessing the viability of clinical trials across clinical research sites. This position conducts comprehensive feasibility assessments, evaluates study protocols, and collaborates with internal teams to support the successful execution of clinical trials. 

Duties and Responsibilities 
  • Gather and analyze historical data, site metrics, and patient demographics to provide evidence-based recommendations on site selection and feasibility. 
  • Identify and screen potential clinical research sites based on study-specific criteria, including patient demographics, geographic location, and investigator expertise. 
  • Collaborate with site staff to assess their capacity, capabilities, and resources to conduct proposed trials. 
  • Conduct detailed feasibility assessments to evaluate site capacity for patient recruitment, protocol adherence, and data quality. 
  • Analyze the availability of target patient populations within each site’s catchment area to assess recruitment potential, estimate recruitment timelines, and identify strategies to mitigate recruitment challenges. 
  • Provide analysis of site-specific cost considerations and budget development, including staffing, equipment, and other resources. 
  • Assess local regulatory requirements and their impact on site feasibility and study timelines. 
  • Work closely with internal study teams, investigators, and sponsors to communicate feasibility findings and address site-specific concerns. 
  • Prepare comprehensive feasibility reports and present results to internal stakeholders, providing actionable insights to support study planning. 
  • Perform other job-related duties as requested or required. 
Required Skills and Abilities 
  • Sound knowledge of medical terminology. 

  • Sound knowledge of ICH/GCP, regulatory requirements, and FDA and HIPAA policies and practices. 

  • Excellent interpersonal skills, with the ability to interact effectively with clinicians, patients, administrators, auxiliary personnel, regulators, monitors, and sponsors. 

  • Ability to work independently, prioritize effectively, seek input, solve problems, and work collaboratively in a team environment. 

  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients. 

  • Meticulous attention to detail. 

  • Ability to maintain confidentiality. 

  • Strong written communication skills. 

  • Strong organizational skills. 

  • Proficiency in Microsoft Office, Microsoft Excel, and Adobe Acrobat. 

  • Ability to meet multiple and changing deadlines. 

  • Ability to consult numerous sources of information to prepare documents. 

  • Fluency in spoken and written English. 

Education and Experience 
  • Bachelor’s degree required, preferably in life sciences, healthcare, or a related field. 

  • At least one year of experience in site feasibility or study start-up within a multi-site clinical research organization. 

  • Strong understanding of clinical trial methodology and regulatory guidelines required. 

Lisamarie O'Brien Business Development

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