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Senior Regulatory Specialist - REMOTE
Location:
Pune, Maharashtra
Description:
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
Company:
Lifelancer
Posted:
May 9 on Manatal ATS
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More About this Listing: Senior Regulatory Specialist - REMOTE
Senior Regulatory Specialist - REMOTE is a Jobs Regulatory Affairs Specialist Job at Lifelancer located in Pune MH. Find other listings like Senior Regulatory Specialist - REMOTE by searching Oodle for Jobs Regulatory Affairs Specialist Jobs.
Senior Regulatory Specialist - REMOTE is a Jobs Regulatory Affairs Specialist Job at Lifelancer located in Pune MH. Find other listings like Senior Regulatory Specialist - REMOTE by searching Oodle for Jobs Regulatory Affairs Specialist Jobs.