Regulatory Specialist Job at Velocity Clinical Research. Apply Now!
Velocity Clinical Research is seeking a detail-oriented Regulatory Specialist I to join its mission of advancing medical treatments through high-quality clinical research. This role involves preparing and maintaining essential regulatory documents, ensuring compliance with IRB requirements, and supporting efficient study startup. If you’re passionate about clinical research and regulatory processes, this is your opportunity to make a difference.
Job Role: Specialist I, Regulatory
Location: Hyderabad, Telangana, India
Role & Responsibilities:
- Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
- Supports initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited study start up
- Ensures regulatory submissions are done in a timely manner as to not delay study start up
- Prepare and submit amendments, yearly requests for continuing approval of open protocols, audits, deviations, adverse event reports, and any other IRB-required submissions.
- Work with staff members to complete Financial Disclosure Forms for each study.
- Assist new hires in completing and submitting all required research documentation and trainings by their deadlines.
- Assist coordinators and site leadership in tracking the training status for existing staff, assisting with updates as needed.
- Assist coordinators in ensuring that all staff on the delegation of authority logs have the appropriate training on file preferred for Regulatory Specialist I Job .
- Maintain study binder, paper or electronic as appropriate, with all IRB related documents and correspondence for each study to ensure audit readiness at all times.
- Notify staff and Site Manager/Director of upcoming training expiration dates
- Assist site leadership and coordinators in the preparation for monitoring visits, sponsor audits, and regulatory audits by conducting quality checks of the regulatory binder.
- Assist with the preparation and submission of closeout documents to the sponsors and IRBs including ensuring completeness, audit-readiness and closure of the regulatory binder and appropriate archival of trial data.
- Supports maintenance oof DOA logs and any other required logs as needed
- Submit or support SAE and AE submissions to the IRB as needed and in a timely fashion
- Supports audit and inspection readiness by ensuring accurate and timely file completion.
- Provide copies of IRB documents to sponsors, as needed.
- Adhere to safety and compliance regulations.
- Other duties as assigned
Education/Experience for Regulatory Specialist I Job :
- Bachelor’s degree with 1 year of relevant experience in the life science industry OR
- Associate’s degree with 2 years of relevant experience in the life science industry OR
- High School Graduate and/or technical degree with a minimum of 3 years relevant experience in the life science industry
Required Skills:
- Demonstrated knowledge of medical terminology
- Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.
- Demonstrated verbal, written, and organizational skills
- Demonstrated interpersonal and communication skills
- Demonstrated ability to work as a team player as Regulatory Specialist I Job
- Demonstrated ability to read, write, and speak English
- Demonstrated ability to multi-task
- Demonstrated ability to follow written guidelines
- Demonstrated ability to work independently, plan and prioritize with some guidance
- Demonstrated ability to be flexible/adapt according to the needs of the clinic priortization
- Must be detail oriented
- Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised
- Demonstrated understanding of ICH, GCP, and FDA regulatory requirements
Required Physical Abilities for Regulatory Specialist I Job :
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- Sit or stand for long periods of time
- Travel locally and nationally
- Communicate in person and by a telephone
- Limited walking required
- Limited to lifting up to 30 pounds
Keywords: Specialist I, Regulatory, Velocity Clinical Research, Clinical Research, Regulatory Specialist, Life Science Industry
