Assist with the management and execution of clinical studies in accordance with applicable regulations
Coordinate project deliverables such as team meetings, budgets, and timelines
Assist with the development and planning of clinical study strategies and protocols
Oversee and provide clinical input for the design of Case Report Forms and electronic databases
Assist with preparation of regulatory applications and documentation needed to conduct studies
Monitor or co-monitor clinical study sites for compliance with approved study protocols
Maintain accurate study tracking documents and systems
Prepare and give clinical presentations as required
Support Data Monitoring Committees if applicable
Assist management of study vendors for compliance to study plans

Requirements

Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management
Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation
Working knowledge of medical terminology
Capability and willingness to learn device function
Ability to interface effectively with medical professionals
Strong analytical and organization skills, with excellent attention to detail and accuracy
Project oversight and tracking capability
Experience with electronic data capture (EDC) and clinical trial management systems (CTMS)
Ability to travel as necessary to clinical centers to establish and manage clinical studies
Experience as a Project Coordinator/Manager is a plus.

Benefits

Health benefits – Medical, Dental, Vision
Personal and Vacation Time
Retirement & Savings Plan (401K)
Employee Stock Purchase Plan
Training & Education Assistance
Bonus Referral Program
Service Awards
Employee Recognition Program
Flexible Work Schedules

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical study managementclinical trial project managementregulatory applications preparationCase Report Forms designelectronic databases managementdata monitoringproject oversightanalytical skillsmedical terminology knowledgestudy tracking

Soft Skills

organizational skillsattention to detailcommunication skillsinterpersonal skillsability to interface with medical professionalswillingness to learnteam coordinationpresentation skillscompliance monitoringvendor management

Certifications

GCP certificationISO14155 certification