LVN / Clinical Research Associate III, Vaccine Clinical Trials
2 months ago
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
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