Specialist, Clinical Trial Services - Cook Inc
Cook Medical - Bloomington, IN

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Medical Product Manufacturing

Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future.

Job Functions/Duties (may include other duties as assigned)
  • Develop and implement study specific procedures for sponsored clinical studies
  • Collaborate with Regulatory Science in the development of appropriate clinical trial submissions
  • Administer study specific clinical research site selection activities
  • Serve as Cook Incorporated liaison for addressing issues pertaining to budget and contract negotiations
  • Ensure investigational device stock availability working with Operations and Engineering to ensure supply is adequate to initiate and complete study specific trials
  • Ensure device accountability is maintained
  • Assist in securing regulatory approvals for live/pre-recorded case demonstrations
  • Assure appropriate agreements are obtained for global/national principal investigators and steering committee members
  • Assure accurate and timely reimbursement to clinical sites, global/national principal investigators and steering committee members in accordance with the contracts and Cook policies and procedures
  • Ensure the stability, reliability and quality of data across the organization via ongoing database support and maintenance
  • Plan effective investigator meetings with Regulatory Science and the SBU
  • Assure required reporting to FDA relating to progress of clinical trials, unanticipated adverse device effect reports, etc.
  • Work closely with the SBU to develop study specific materials including data sheets, pocket cards, physician website, recruitment materials, etc.
  • Collaborate with Clinical Trial Project Managers to establish time lines, tasks, and resource requirements needed
  • Ensure compliance with applicable regulations as a study sponsor
  • Maintain sponsor clinical trial records in accordance with approved methods
  • Serve as company liaison to work with clinical sites to resolve any site-related issues
  • Participate in Regulatory Affairs Clinical Trial Services process improvement initiatives
  • Other duties as assigned

    Work Experience

  • Experience in clinical/scientific research, nursing, or medical devices/pharmaceutical industry preferred
  • Experience working on cross-functional teams
  • Basic computer literacy (e.g., Windows, Word, Excel, PowerPoint, Access)
  • Effective analytical and problem solving skills
  • Ability to coordinate multiple projects simultaneously
  • Ability to comply with written procedures and instructions

    Education

  • Bachelor’s degree in health/science or business related field

    Our Benefits

  • Base Salary
  • Teamwork bonus
  • 401(k) retirement savings plan with company match
  • Profit sharing
  • Medical, dental, and vision
  • Life insurance
  • Paid time off
  • Flexible spending account
  • Educational assistance/reimbursement

    Cook is an Equal Opportunity Employer

About this company
28 reviews
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...