Job DescriptionWhat will you be doing in this role?The Research Program Administrator works with the Principal Investigator or Department Head to coordinate all aspects of building a research program. This will included, development of infrastructure, overseeing clinical research staff, quality assurance, and coordination of grant activities and grant proposals. Administrator will identify improvement areas, prepare policies, train staff, and audit procedures to create an efficient clinical research program. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
ResponsibilitiesPrimary Duties & Responsibilities:- With the Principal Investigator or Department Head, coordinates all aspects of building a research program including the development of infrastructure and new research programs.
- Oversees an entire research program or group of Clinical Research Coordinators, Clinical Research Assistants, Clinical Research Associates, and/or Research Nurses.
- Oversees research Quality Assurance and Quality Control within their department or division.
- Coordinates grant activities pre award through closure (monitoring budgets, compliance, progress reports).
- Identifies process improvement areas to assure an efficient and robust clinical research program.
- Data compilation, assists with grant proposals, protocol development, scientific publication preparation, and presentations.
- May train junior research staff members.
- Involved in centralized activities such as auditing and preparation of clinical research policies and standard operating procedures.
- Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
QualificationsEducation:- Bachelor's Degree is required.
Experience and Skills:- Five (5) years of directly related experience is required.
Licenses and Certifications:- Certification In Clinical Research (ACRP/SoCRA) is preferred
