Irb Lead Analyst Jobs

Excellent time management skills and meet deadlines

Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System.

Previous experience working with online/web-based platforms for clinical trial management systems

Manage the regulatory tracking and archive systems (e.g. SharePoint, Clinical Trials Management System, shared network drive, etc.).

A minimum two years of regulatory, human research protection or related experience in a research environment.

Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols.

Time management skills and the flexibility to accommodate changing priorities in unit.

Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology

Bachelor's degree in related area and three or more years of relevant expierience and / or equivalent experience / training

Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents

Independence, planning and decision-making abilities to complete assigned duties.

Excellent customer service skills, pleasant, helpful, and patient.

Critical thinking skills; Delegation skills

Written and verbal communication skills

Clinical skills appropriate to position

Knowledge of regulatory standards appropriate to position

Computer skills appropriate to position

Interpersonal skills; Customer service skills

Solid PC skills including thorough knowledge of MS Office functions, and electronic database tracking systems.

Outstanding interpersonal and organization skills, a collaborative style, and experience working with faculty, staff and students in achieving their research goals.

Provides education and training to reviewers, faculty researchers and staff on a wide variety of topics.

Minimum of five (5) years of human subjects’ research experience.

Must have demonstrated knowledge and understanding of the IRB process.

Demonstrated verbal and writing skills in addition to great problem-solving, self-initiation, and decision-making skills.

Experience reviewing FDA-regulated biomedical research is required.

This opportunity is full-time, remote position for approximately 1 year. This is a consultant (contractor) role.

Conduct exempt reviews and issuing exempt determinations

Serve as expedited reviewers appointed to the IRB in such capacity

Engage with the Client’s research community as needed to answer questions, provide guidance on IRB applications, and support research operations