Specialist I, Regulatory

Overview:

We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Summary:

The Regualtory Specialist I prepares and maintains complete and accurate regulatory documents in support of clinical research studies.

Responsibilities:

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.
• 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:

Education/Experience:

• 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 minimum of 3 years relevant experience in the life science industry

Required Licenses/Certifications:

• None

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
• 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 Abilites:

• 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

All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.