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Velocity Clinical Research

Compare

3.8

based on 7 Reviews

4 Velocity Clinical Research Jobs

Specialist I, Regulatory

Velocity Clinical Research, Inc.

3.8

based on 7 Reviews

1-5 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Specialist I, Regulatory

Velocity Clinical Research

posted 9d ago

Job Role Insights

Flexible timing

Key skills for the job

Research Clinical Research Auditing MS Office Training GCP

+ 3 more

Job Description

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.
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 Qualifications