Manager, Regulatory

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:

A Manager, who is well versed in study start up to include but not limited to regulatory, source and the delivery of key documents in order to deliver study start up.

Role & Responsibilities:

• Manages a team of regulatory specialists.
• Proactively manages regulatory, challenges the status quo, and works to drive change and efficiency.

• Ensures regulatory submissions are done in a timely manner as to not delay study start up.
• Can support in the preparation of study specific protocol, informed consent form, HIPAA authorization and other related documents for review by the IRB. 
• Could 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 provide guidance and direction to complete conflict of interest paperwork as needed. 
• Supports team as a manager and mentor in what maintenance of the study binder should look like with all IRB related documents and correspondence for each study. 

• Can make suggestions or implement ideas to break down barriers and achieve corporate objectives.
• Proactive acts as an out of the box thinker and leader to meet the objectives of study start up.
• Provides, develops, and creates regular reporting to executive management to demonstrate progress of study start up.
• Proactively identifies gaps in start up to address potential gaps and areas of vulnerability.

• Supports in the maintenance of electronic regulatory files, including tracking document history. 
• Could support and 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.
• Works with the Velocity IRB of record to submit generic site material.
• Other duties as assigned.

Required Skills/Abilities:

• 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 prioritization.
• 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 and team builder
• Advanced understanding of ICH, GCP, and FDA regulatory requirements

Education and Experience:

• High School Graduate and/or technical degree required
• Bachelor’s degree or Associate’s degree preferred
• Minimum of four (4) to six (6) years of clincal research regulatory experience preferred
• Two (2) to three (3) years previous supervisory experience preferred

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.