IRB Analyst - Randstad Digital

Performs regulatory and/or administrative review and analysis of research study submissions to the Review Board for consistency, completeness, and compliance with federal and state regulations and IRB policies and procedures.

Essential Responsibilities:

1. Comprehension of and ability to problem solve within the framework of federal regulations, laws, and guidance pertaining to human subject protections, including 45 CFR 46, 21CFR50, 56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report, and the IRB Policies and procedures in order to identify issues or concerns that must be addressed in order to approve research study submissions.

2. Acts as point person for questions, and for decision-making and problem-solving for day-to-day IRB operations including the resolution of technical problems and questions of IRB members, researchers and investigators.

3. Communicates with investigators or IRB Committee members to facilitate the review process while incorporating complex scientific and regulatory language and concepts, in addition to relevant ethical concerns, if any.

4. Provides guidance to research coordinators and investigators regarding applications in preparation for submission to IRB.

5. Ability to manage several projects at once and ability to work under pressure. In addition to the job description please provide the following information:

location: Oakland, California

job type: Contract

salary: $70 - 75 per hour

work hours: 8am to 5pm

education: Bachelors

responsibilities:

• Doing pre-review of IRB Submissions, Completing Expedited IRB reviews, Completing administrative IRB reviews.
• Staffs and coordinates the IRB by preparing and previewing items on the IRB meeting agendas, attends IRB meetings, records and assists in writing IRB meeting minutes, and follow-up correspondence.
• Communicates with investigators to facilitate the review process while incorporating complex scientific and regulatory language and concepts.
• Advise and counsel on matters of general research compliance and ethical human participant research practices.

qualifications:

• Seeking 3-5 years of relevant experience
  • Knowledge of Electronic IRB systems
  • Knowledge of IRBNet preferred
  • Doing pre-review of IRB Submissions, Completing Expedited IRB reviews, Completing administrative IRB reviews
  • Knowledge of human subjects protection and IRB Federal regulations.
  • Strong written and verbal communication skills.
  • Ability to quickly learn IRB processes
  • IRB/HRPP experience

Preferred: Has a working knowledge of scientific and medical concepts and terminology. Experience reviewing Exempt and/or Expedited research. Ideal candidates would have experience working in an IRB or regulatory department and providing either regulatory or administrative support to an IRB Committee. Demonstrated strong interpersonal, oral and written communication skills.

skills:

• Detail Oriented
• Strong Communicator
• Self Motivated
• Team Player

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad Digital, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad Digital offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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