Senior Specialist, Regulatory

Job Description

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 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 Velocity 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 Velocity 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

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.

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