Mentors nursing staff and students in Research, QI and EBP projects.
Collects study data, assists in developing data collection tools, study materials, communication and performs departmental in-services
Performs related responsibilities as required
Consults with the Executive Director Nursing Excellence & Research and Research Administration staff regarding the study implementation and IRB application process
Study/Project Initiation:
Plan, organize, implement studies and projects to effectively meet goals and ensure timely completion.
Manage and communicate effectively with Executive Director Nursing Excellence & Research regarding proposed projects for feasibility, including, analyzing scope of work, cost and responding to inquiries and/or complaints
Reviews protocols for potential operational issues and makes recommendations, as needed
Creates informed consents
Submits protocol, informed consents and necessary documents to Institutional Review Board (IRB) for approvals; communicate with IRB on a regular schedule if applicable
Communicates with Executive Director Nursing Excellence & Research regarding study initiation needs.
Develop study specific materials, e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals.
Prepare study reports, e.g., modification, amendments, Investigational New Drug (IND) reports, etc.
Perform yearly review of studies, completing yearly documents required by sponsor, IRB and FDA.
Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design.
Ensure the statistical analysis plan is complete, if applicable.
Ensure information is available for final study report completion.
Communicate with Research Manager regarding resource needs and issues, e.g., supplies, equipment, etc.
Study Completion:
Complete study close out procedures.
Submit closeout documents to sponsor and IRB.
Compose year end status report for Research Manager and research staff.
Return study product, if applicable.
Submit yearly post study documents, as required.
Ensure study material are stored and maintained for appropriate time line.
Administration:
Demonstrate ability to prioritize multiple projects.
Proven ability to independently resolve problems.
Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines.
Work in a fast paced environment with demonstrated ability to perform multiple competing tasks and demands.
Work independently, take initiative and complete tasks to deadlines.
Participate in the training of other research staff as assigned.
Track project milestones and report progress and issues to Executive Director Nursing Excellence and Research
Creates and promotes positive team morale.
Identify skill deficiencies, and appropriate training work experience to eliminate a skill gap
Attend related courses, seminars, and meetings.
Ensure that skills are continually sharpened and that learning and competency building are focused on routinely.
Read professional journals and publications to stay abreast of regulations and study management and to learn scientific area.
Obtain information from the field on relevant new scientific developments that identifies needs for staff training, if applicable.
Serve as a department resource for general study related issues.
Create and/or deliver project specific training to ensure adequate training specific to project requirement, e.g., project overview, study protocol information.
Assist in providing/obtaining training that is role specific, e.g., monitoring GCP, ICH, SOPs and FDA.
Participate in company-required training programs.
Maintain time and attendance records.
Performs other related job duties or functions as requested or assigned.
