Senior Clinical Data Coordinator C

Overview -

• The Investigator Sponsored Studies (ISS) Associate I plays a key role in supporting Medical Device Medical Affairs by managing Investigator Sponsored Study documentation and processes.
• This position is responsible for accurately entering reviewing verifying and organizing clinical documentation using web-based systems while ensuring compliance with internal procedures Quality Management Systems (QMS) and applicable regulatory requirements.
• he role requires strong attention to detail initiative problem-solving skills and the ability to collaborate across cross-functional teams.

Responsibilities -

• Process incoming ISS forms accurately and in accordance with departmental procedures.
  
• Perform timely and accurate data entry into databases and conduct quality review and verification of submitted forms.
  
• Identify correct and prevent documentation errors; organize clinical documentation correspondence and supporting records.
  
• Analyze issues characterize problems and recommend appropriate solutions to improve process efficiency and quality.
  
• Provide administrative support for ISS activities including mail merges faxing copying filing and mailings.
  
• Proactively identify root causes of issues and facilitate resolution to prevent recurrence.
  
• Communicate with customers study coordinators and field clinical engineers to clarify missing or inconsistent data.
  
• Support company initiatives related to QMS Environmental Management Systems (EMS) and other regulatory requirements.
  
• Ensure compliance with FDA regulations company policies and operating procedures.
  
• Collaborate effectively with internal teams contractors vendors and external stakeholders.
  
• Participate in cross-training across all ISS processes supported by Medical Device Medical Affairs.

Qualifications & Requirements -

• Experience as a Clinical Data Coordinator or in a comparable clinical research or data management environment.
  
• Strong proficiency in MS Office applications particularly Excel Word and PowerPoint.
• Demonstrated ability to work independently with limited supervision while managing multiple priorities.
  
• High level of organizational skill and attention to detail.
  
• Ability to understand and comply with FDA regulations company procedures and regulatory standards.
  
• Strong interpersonal and communication skills including the ability to resolve moderately complex issues.
  
• Ability to handle sensitive and confidential information with discretion.
  
• Willingness to work occasional overtime as required.
  
• High school diploma required; Bachelor s degree preferred.
  
• Medical or pharmaceutical industry experience required to understand terminology and document meaningful discussions.

Must-Have -

• Clinical data management or clinical research coordination experience
• Strong writing and documentation skills
• Advanced Excel skills
• Ability to enhance and improve existing tools and processes
• Familiarity with FDA-regulated environments
• Experience working with systems such as:
  • Excel Word Outlook MS Teams
  • Adobe PDF DocuSign
  • Chrome Salesforce (contracts)
  • Concur Ariba OwnIt I Envision Blackboard

Preferred / Nice-to-Have

• Bachelor s degree or equivalent combination of education and experience
• Experience with FDA GMP and GCP regulations
• Prior experience using Concur for payments
• Experience working in a highly matrixed and geographically diverse environment
• Background supporting medical device or pharmaceutical studies