Senior Regulatory Specialist - REMOTE

About the job:

Summary:

The Senior Regulatory Specialist is the subject matter expert and leader of a regulatory team to prepare and maintain complete and accurate regulatory documents in support of clinical research studies.

Role Responsibilities:

• Leads a team of multiple regulatory specialists supporting one or more Clinical Research sites
• Ensures regulatory submissions are done in a timely manner as to not delay study start up.
• Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
• Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, adverse event reports, and any other IRB-required submissions.
• Work with staff members to complete conflict of interest paperwork for each study.
• Assist new hires in completing and submitting all required research documentation and trainings.
• Track training status for existing staff, assisting with updates as needed.
• Maintain study binder with all IRB related documents and correspondence for each study.
• Maintain electronic regulatory files, including tracking document history.
• Maintain a database of staff listings and training dates.
• Pro-actively notify staff and Site Manager/Director of upcoming training expiration dates to maintain compliance
• Coordinate meetings with auditors to review paper and electronic regulatory files and inspectors.
• Provide copies of IRB documents to sponsors, as needed.
• Adhere to safety and compliance regulations.
• Stay abreast of evolving regulatory trends and work with the Site Manager/Site Director to ensure compliance with changes in the regulations
• Ensures binder accuracy, completeness and inspection readiness
• Prepare local IRB submissions
• Review ICFs for completeness - ensure the California Bill of Rights is included as applicable, subject stipends are accurate, and all protocol procedures are captured in the ICF
• Ensures that ICFs and other study documents are available in any language as required by the site and approved by the IRB
• Works with the IRB of record to submit generic site material
• Other duties as assigned

Education/Experience:

• Bachelors degree and 4 years of clinical research regulatory experience OR
• Associates degree with 6 years of clinical research regulatory experience OR
• High School Graduate and/or technical degree with minimum of 8 years of clinical research regulatory experience

Required Licenses/Certifications:

None

Certified Clinical Research Professional a plus

Required Skills:

• Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Proficient ability to work in a fast paced environment
• Advanced verbal, written, and organizational skills
• Advanced interpersonal and communication skills
• Advanced ability to work as a team player
• Advanced ability to read, write, and speak English
• Demonstrated ability to multi-task
• Demonstrated ability to mentor and train
• Advanced ability to follow written guidelines
• Proficient ability to work independently, plan and prioritize with minimal guidance
• Proficient ability to be flexible/adapt according to the needs of the clinic priortization
• Must be detailed oriented and can demonstrate attention to detail
• Proficient problem solving and strategic decision making ability.
• Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised
• Proficient leader, mentor an team builder
• Advanced understanding of ICH, GCP, and FDA regulatory requirements

Please use the below link for job application and quicker response.

https://lifelancer.com/jobs/view/dab08e76414b56003ec876f4d643ec67