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 IRBrequired 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.
• Proactively 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 multiline 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 multitask
• 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.

Remote Work :

No