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Clinical Project Associate

1 hour, 14 minutes ago
United States
Full-time
Junior
Project Coordinator
Project and Program Management
Apply Now
OrganOx

OrganOx

OrganOx is a medical equipment manufacturing company that specializes in normothermic machine perfusion devices for organ preservation. Their core technology, the OrganOx metra®, enables the functional assessment of donor organs prior to transplantatio...

Health Care Providers & Services
11-50
Founded 2008
$13M raised
View All Jobs 2

Description

  • Support the conduct of clinical investigations across study initiation, enrollment, and study closure phases.
  • Conduct on-site, remote, and centralized monitoring visits with oversight and within required timelines.
  • Review and help develop study documents, protocols, data collection tools, training materials, and database-related materials.
  • Assist sites with IRB submissions, renewals, and ongoing compliance requirements.
  • Maintain complete and accurate in-house study files and audit them for compliance with internal standards.
  • Train site personnel, investigators, and field staff on protocol requirements and timely data collection.
  • Review submitted clinical data for completeness, accuracy, scientific validity, and discrepancy resolution.
  • Identify and escalate compliance, regulatory, logistical, and operational issues and support corrective action plans.
  • Prepare monitoring visit reports, follow-up letters, queries, and action items and track them to resolution.
  • Collaborate with investigators, site coordinators, clinical management, and other internal departments as needed.

Requirements

  • Bachelor’s or graduate degree in a life science, nursing, or other health-related discipline.
  • 2 years of clinical research experience in medical device, pharmaceutical, CRO, CRA, clinical trial assistant, research site, or similar roles.
  • Strong working knowledge of FDA regulations and ICH/GCP guidelines governing clinical trials.
  • Current CCRA or CCRP certification preferred.
  • Preferred experience or aptitude in transplant surgery and/or medical device research.
  • Valid U.S. driver’s license required.
  • Ability to travel 10% of the time.
  • Proficiency with word processing, spreadsheets, and database applications such as MS Word and Excel.
  • High attention to detail, accuracy, and excellent time management and organizational skills.
  • Excellent professional writing, oral communication, and interpersonal skills, with the ability to work independently and as part of a team.

Benefits

  • Competitive compensation.
  • Comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts.
  • 401(k) retirement plan with company matching after 90 days.
  • Paid time off, holidays, and additional leave benefits.
  • Employee discounts.
  • Access to an onsite wellness facility.
  • Work-life balance support.
  • Opportunities for ongoing professional development.

Interested in this position?

Apply directly on the company website

Apply Now

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