Provide logistical support to Scientific Review Advisory Committee (SARC) and Investigational Product Review Committee (IPRC), including scheduling meetings and uploading documents
Notify reviewers when materials are available for review and ensure reviewers are aware of meeting dates and times
Create meeting minutes, draft post review memos and notifications, and upload final documents
Work closely with committee chairs and members and oversee communication channels (intranet site, meeting announcements, emails)
Maintain a uniform and high-quality standard of support by communicating with research teams, implementation/support teams, project managers, health system representatives, consultants, and vendors
Collaborate with system manager and director on development and maintenance of policies and Standard Operating Procedures (SOPs)
Provide high level customer support with timely and accurate responses and solutions to user needs and engage in problem solving with study teams
Process HSR Portal submissions and communicate with study teams, departments, and committees about submissions
Provide support to the Director, Clinical Research Administration, and perform other duties as assigned
Requirements
Bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business
1 year of professional level experience with clinical research or research applications
Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis
Preferred: Two (2) or more years of professional experience in a clinical research setting, preferably at a medical center
Preferred: Experience translating regulatory issues and challenges into clinical research concepts and operations
Preferred: Experience analyzing business operations or workflows, finding efficiencies, and implementing improvements
Strong troubleshooting background
Ability to communicate effectively, both in writing and orally
Ability to establish and maintain effective working relationships with employees at all levels
Diplomatic disposition and customer service orientation
Strong team player
Ability to work with minimal supervision, meet deadlines and expectations
Quick and agile learner, able to adapt to changes in technology
Able to coordinate and prioritize several simultaneous tasks with potentially conflicting priorities
Able to synthesize complex clinical trial information to facilitate decision making
Familiarity with terminology and processes associated with all phases of clinical research
Familiarity with the concepts of relational databases, normalization, and how databases are used by applications
High proficiency in Microsoft Windows and Office
Application materials required: Cover Letter, Resume/CV, Three to five professional references
Benefits
Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay