Clinical Trial Coordinator

← All Job Openings

Description:

Bluejay Diagnostics is a medical diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression. To help us with our mission, we are searching for a Clinical Trial Coordinator. Under the direction of the Chief Technology Officer and Chief Medical Advisor, the Clinical Trial Coordinator will develop, implement, and coordinate study and administrative procedures for the successful management of clinical trials. The Clinical Trial Coordinator will perform various administrative duties requiring analysis, sound judgment, attention to detail, and knowledge of study details.

Responsibilities:

  • Coordinates and supports activities for clinical studies.
  • Assists Clinical Affairs team with development of study specific documents.
  • Responsible for set-up, maintenance, and archival of clinical trial documents.
  • Collects and tracks regulatory documents for multiple studies to ensure completeness of Trial Master File (TMF) and audit readiness.
  • Coordinates the signing of agreements with study sites (Confidential Disclosure Agreements (CDAs)) and related documents.
  • Provides study documents (Protocol, etc.) to clinical sites.
  • Expedites study specific payments when necessary.
  • Communicates with investigators, hospital research, and legal staff to coordinate execution of a study.
  • Provides summary information related to studies to Senior Management.
  • Responsible for study device/disposables shipments, accountability, and reconciliation.
  • Ensures compliance to applicable clinical study regulations and Bluejay SOPs, WIs, and policies.
  • Perform other related duties as assigned.

Requirements:

  • Associates or Bachelor’s degree in a scientific, healthcare, or business related field is preferred.
  • Must have a minimum of one year of experience working for a medical device/biotech/ pharmaceutical company, preferably in a Medical Affairs-related function.
  • Ability to travel up to 10% of the time.
  • Ability to support multiple studies for Bluejay at different locations.
  • Well organized, detail oriented, and accountable.
  • Strong written, oral, and interpersonal communication skills.
  • Flexible, self-motivated, and works well under pressure in a dynamic environment.
  • Proficiency with Microsoft Office and electronic quality management (eQMS) systems.
  • Some experience with data analysis is preferred.

Benefits:

  • Medical, Dental and Vision insurance
  • Paid time off
  • Parental leave
  • 401(k) plan with company match
  • Flexible spending account

Industry: Medical Device and In Vitro Diagnostics
Job Type: Full Time

Apply for this position

Allowed Type(s): .pdf, .doc, .docx