Specialist II, Regulatory

Overview:

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. 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 II supports a team in the preparation and maintenance of complete and accurate regulatory documents in support of clinical research studies.

Responsibilities:

Role & Responsibilities:

• Leads a team of multiple regulatory specialists and/or clinical research coordinators in supporting one or more Velocity Clinical
• Prepare each study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB.
• Prepare initial regulatory submission documents for IRB and sponsors to ensure site meets regulatory readiness metrics with a focus on expedited 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.
• Track training status for existing staff, assisting with updates as needed.
• Assist coordinators in ensuring that all staff on the delegation of authority logs have 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.
• Maintain a database of staff listings and training dates.
• 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.
• Coordinate meetings with auditors to review paper and electronic regulatory files.
• Ensures consistency of regulatory documents across sites.
• Ensure close out documents are prepared and submitted to sponsors and IRB. Ensure documents are complete, audit-ready, and that the regulatory binder is closed and archived.
• 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 and when necessary, Velocity QA to ensure compliance with changes in the regulations
• Prepare local IRB and IBC submissions
• Review ICFs for completeness - ensure the California Bill of Rights is included as appliable, 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 Velocity IRB of record to submit generic site material
• Other duties as assigned

Qualifications:

Education/Experience:

• Bachelor's degree and 2 years of relevant experience in the life science industry OR
• Associate's degree with 4 years relevant experience in the life science industry OR
• High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry

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
• Proficient verbal, written, and organizational skills
• Proficient interpersonal and communication skills
• Proficient ability to work as a team player
• Proficient ability to read, write, and speak English
• Proficient ability to multi-task
• Proficient 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 prioritization
• Must be detail oriented
• Demonstrated problem solving ability.
• Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised
• Demonstrated leadership ability
• Proficient understanding of ICH, GCP, and FDA regulatory requirements
• Should be able to provide on the job training and mentor junior staff as needed.

Required Physical Abilities:

• 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

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.