• Job Description

  Req#: 26-07382
  
  
  Onsite M-F;
  The main function of the Clinical Research Specialist is to support clinical study start‐up, execution, and closeout with a strong emphasis on maintaining an inspection‐ready Trial Master File (TMF). Responsibilities include organizing, reviewing, and quality‐checking essential documents in the eTMF and CTMS to ensure compliance with GCP, regulatory requirements, and internal SOPs. The Specialist identifies and investigates documentation discrepancies, supports data review and query resolution with cross‐functional teams, and contributes to process improvements that enhance efficiency and documentation quality across clinical studies.
  Key Responsibilities:
  Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit, and other associated supporting tasks), as well as study execution and closure activities Organize and manage documents in the Electronic Trial Master File (eTMF) and Clinical Trial Management System (CTMS) to ensure compliance with internal procedures. Review clinical data for completeness across multiple research trials and conduct thorough documentation reviews for internal and external audits (e.g., FDA, TUV, PMDA) to ensure all essential Trial Master File (TMF) documents adhere to Good Documentation Practices, Edwards' internal SOPs, and relevant US and OUS regulations.
  
  Review, identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study conduct and closeout
  
  Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
  
  Supports assessments of current processes, identifies opportunities and assists with improving process efficiency within and across related functional areas
  Education and Experience Requirements:
  Bachelor's Degree or equivalent in related field
  1-2 year of clinical research experience required
  
  Additional Skills (Preferred):
  
  
  • Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred.
  
  
  • Good written and verbal communication skills and interpersonal relationship skills
  
  
  • Good problem-solving and critical thinking skills
  
  
  • Good understanding of medical device regulatory requirements and documents, device accountability and adverse events reporting
  
  
  • Strict attention to detail
  
  
  • Ability to manage competing priorities in a fast paced environment
  
  
  • Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
  
  
  
  
  
  Shift: []
  
  Start: []
  
  EEO:
  
  “Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”
  

• About the company

  Mindlance is one of the largest diversity-owned staffing firms in the US . As a recruitment centric talent acquisition company, Mindlance provides Technology, Engineering, Digital / Creative / Marketing, Clinical Research, Scientific, Finance, Professional and Payroll Management staffing services to Global 1000 companies across the US, Canada and India.

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