This position serves as a project manager and point of contact for assigned clients and may serve as a Non-Scientific Board Member. Additionally, exhibits and instills in staff members a customer service and quality focused approach and promotes client loyalty by providing excellent customer service in the management of study activities.
This role offers work from home opportunity!!!!
Maintains compliance with Federal Regulations, ICH Guidelines, Standard Operating Procedures (SOPs), and company policies
Establishes relationships with assigned clients to become intimately familiar with the specific requirements of each client
Analyze input from clients to identify trends, strengths and weaknesses and work with management to implement necessary change
Serves as the primary point of contact for clients and responds to client inquiries in a professional and timely manner
Communicates effectively with clients, staff members, board members, investigators, and study personnel to identify and resolve issues
Prepares and delivers presentations on study reporting requirements, processes, and study start-up training
Performs pre-review of IRB submissions, study protocols, and draft consent forms in accordance with Salus IRB policy, federal regulations and ICH guidelines, and advises client of recommended or required changes for clarity, accuracy, and compliance with federal regulations and Salus IRB policy prior to board review
Establishes and maintains tracking reports, study progress and milestones
Provides work-direction supervision of client deliverables and ensures the details concerning the flow of services for assigned clients are maintained on an ongoing basis to meet client expectations and established turnaround times
Performs quality review of client deliverables utilizing established procedures prior to distribution to client
BA/BS degree preferred
At least three years experience in IRB or clinical research environment, preferably in clinical trials is required
Working knowledge and interpretation of all IRB-related regulations preferred
Industry certification or willing/able to obtain certification upon becoming eligible
About Salus IRB
As an AAHRPP-accredited IRB, Salus IRB is committed to upholding the highest standards in human research protection while providing the high level of service and expertise that our customers have relied upon for 35 years.