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; ORMinimum 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 / AAdditional 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