Location: Please note since requisition release this group has transitioned locations -- talent will be on-site in Pleasanton, CA -- seeking talent in Pleasanton or surrounding commutable area
The Regulatory Specialist position provides regulatory document support to the Kaiser Permanente Northern California (KPNC) principal investigator and research sites conducting multiple FDA-regulated or other clinical trials. The regulatory specialist position provides operational support for regulatory compliance. This position works in consultation with the principal investigator, sub-investigators and teams members. This position Is also responsible for assisting in protecting the health, safety, and welfare of research participants. This position is a non-licensed position which must adhere to the position's scope of practice.
The Clinical Trial Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency which, under the direction of the KPNC clinical trials administrative management or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Northern California (KPNC) PI and research site(s) conducting multiple FDA-regulated or other clinical trials. The CTRS-II has demonstrated proficiency in providing operational support for Sponsor and IRB regulatory compliance. The CTRS-II works independently and assumes increased responsibilities. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. This is a non-licensed position which must adhere to the positions scope of practice.
- Team is looking for talent that has regulatory submission experience and can speak to why/how - the purpose of regulatory documents, the justifications on why/how things are put in binders - essentially folks with strategy/advise in the space versus just following Clin Trial SOPs or QMS SOPs
- Secondary to this experience in and around clinical trials goes hand in hand with what the group holistically does
location: Oakland, California
job type: Contract
salary: $30 - 32 per hour
work hours: 8am to 4pm
education: High School
responsibilities:
The Clinical Trial Regulatory Specialist II (CTRS-II) is a position with demonstrated proficiency which, under the direction of the KPNC clinical trials administrative management or designee and Principal Investigator (PI), provides regulatory document support to the Kaiser Permanente Northern California (KPNC) PI and research site(s) conducting multiple FDA-regulated or other clinical trials. The CTRS-II has demonstrated proficiency in providing operational support for Sponsor and IRB regulatory compliance. The CTRS-II works independently and assumes increased responsibilities. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. This is a non-licensed position which must adhere to the positions scope of practice.
qualifications:
- Experience level: Experienced
- Minimum 3 years of experience
- Education: High School (required)
skills:
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 HRsupport@randstadusa.com.
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
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.
