Clinical Safety Coordinator
Core
Deliver operational support and ensure compliance for clinical safety activities across medical device studies (EFS/FIH, IDE, Post-Market) to maintain scientific integrity and ethics.
Role type
Clinical Safety Coordinator (IC)
Builds
Clinical safety deliverables, study documentation, and safety reporting for BD Peripheral Intervention business unit
Domain
Medical Technology / Clinical Research
Deliverable
dashboards & analysis | client delivery
Required skills
Microsoft Suite proficiency, organizational skills, critical thinking, ability to lead and delegate tasks, travel readiness
Preferred skills
Knowledge of GCP and clinical research regulations, experience with eTMF/CTMS/CDMS systems, Veeva Vault experience, medical device safety reporting experience, professional certification (ACRP/SOCRA)
Technologies
Microsoft Office Suite, eTMF, CTMS, CDMS, Veeva Vault
Responsibilities
Provide operational support for Clinical Safety management activities; Ensure quality and compliance for safety-related activities; Develop and maintain relationships with investigational site staff and HCP consultants; Facilitate communication between clinical sites and BD stakeholders; Support Trial Master File (TMF) maintenance and perform audits; Support management of study-specific tracking reports; Support development of Clinical Safety Plans and committee charters; Support reporting and escalation of product complaints and safety events; Support safety-related interactions, training, and invoicing for vendors; Participate in safety meetings (CEC, DMC, trending); Provide support for internal or external audits/inspections
Seniority
Entry-level to Mid-level, hands-on IC
