LVN / Clinical Research Associate III, Vaccine Clinical Trials

Job Summary :

Manages day-to-day activities of a major segment(s) of medium to large studies or several smaller studies. May supervise project staff.

Works under general supervision. Final review required for some phases of projects.

Essential Responsibilities :

• Manages day-to-day activities of a major segment(s) of medium to large studies or several smaller studies.
• May assist in development of study tools (e.g. tracking forms, questionnaires, chart review forms, etc.).
• Develops simple study protocols or portions of complex protocols.
• Monitors progress of study activities (e.g. data collection and validation, recruitment, pilot studies, focus groups, etc.).
• May coordinate research project activities with other research study centers.
• Prepares progress reports independently and / or collaboratively.
• May participate in the training of new team members and / or clinical staff.
• If assigned to clinical trial, may work with Sponsors / monitors at clinical sites.
• Adheres to compliance and privacy / confidentiality requirements and standards.
• Adheres to GCP and compliance regulations for clinical trials.
• Assists with and / or oversees quality assurance of study activities; ensures quality data.
• May assist with implementation of quality control measures.
• Acquires and maintains knowledge of KP systems and databases.
• Identifies, recommends and implements solutions to study issues.
• Interfaces with IRB and drafts portions of IRB protocols, amendments, continuing reviews, etc.
• Supervises and manages the day-to-day activities of project staff including evaluating performance.
• May mentor and develop staff and participate in hiring.
• Contributes to portions of study presentations.
• Assists in writing scientific articles.
• Serves as a member on department or study-related committees.
• May recommend budget actions / decisions and manage project budget.
• Reviews scientific literature and drafts portions of background section of grant proposals.
• May contribute to other sections of grants.

Basic Qualifications :

Experience

• Minimum four (4) years of experience in public health, healthcare administration, epidemiology, or healthcare-related field.
• Minimum two (2) years of training and / or professional experience in research methodology / research study design, hypothesis testing; OR
• Minimum two (2) years of experience in clinical protocols involving research methodology / research study design, and hypothesis testing.
• Minimum two (2) years of training and / or experience managing research projects under general guidance.

Education

Bachelors degree in public health, healthcare administration, epidemiology, or health-related field (ex. Biology, Psychology, etc.

OR four (4) years of experience in a directly related field.

High School Diploma or General Education Development (GED) required.

License, Certification, Registration

N / A

Additional Requirements :

• Experience creating flow charts, research instruments (e.g. chart review forms, questionnaires, etc.).
• Experience in quantitative and / or qualitative data interpretation and application.
• Must be able to prepare sections of professional reports and presentations.
• Must be able to work in a Labor / Management Partnership environment.

Preferred Qualifications :

• Minimum one (1) year of direct personnel management preferred.
• Masters degree in public health, healthcare administration, epidemiology or related field.
• Preferred Qualification - LVN (Licensed Vocational Nurse)
• Vaccine / COVID 19 Clinical Trials experience
30+ days ago