Director, Clinical Site

 generating high-quality data from as many patients as possible, as quickly as possible, while delivering exemplary patient care at every step.

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

## The Role

The Clinical Site Director manages the overall business and clinical operations of the site to ensure appropriate targets are met. You'll be responsible for the site's annual and forecast operating budgets and for the efficient coordination, organization, and conduct of clinical trials. This position oversees all aspects of the clinical trial process including study feasibility, clinic staffing, patient recruitment, study conduct, and regulatory compliance. Ultimately, you're responsible for ensuring the health and safety of study patients and staff.

This is a full-time, regular position requiring complete 24/7 control over the overall operations and management of clinical research trials at the site.

## Key Responsibilities

Working with the Senior Director of Clinical Operations, you'll manage the operational budget and meet or exceed the site's financial, operational, and study-specific targets. You'll identify and implement strategies to expand research capabilities at the site in line with overall business and growth plans.

Oversight of Velocity quality standards is essential—you'll ensure the conduct of clinical studies and collection of patient data aligns with ICH GCPs and Velocity SOPs. Collaboration with the Medical Director on study and clinical quality issues is ongoing, as is ensuring timely and appropriate communications with Sponsors, CROs, and IRBs.

Developing site staffing plans to ensure successful and efficient conduct of research studies falls within your purview, as does identifying and fulfilling site resource needs necessary for successful study conduct and recruitment. You'll oversee the development of patient recruitment plans and patient outreach processes, making ongoing adjustments to recruitment strategies based on timely review of results to ensure financial and study-specific targets are met. Close collaboration with external vendors facilitates successful patient enrollment strategies.

Managing site staff performance is a core function. You'll delegate appropriate and challenging assignments to encourage growth, development, and responsibility while ensuring ongoing training needs are met. You're responsible for assuring all site staff complete required trainings, establishing and communicating performance expectations and guidelines, facilitating annual performance evaluations, and identifying and managing issues concerning staff conduct.

Building and maintaining relationships with outside medical practices, pharmacies, and other healthcare professionals and organizations aids in patient recruitment. Conducting business development activities on behalf of the site and Velocity with sponsors, CROs, CRAs, and third-party study vendors is expected as appropriate.

Financial oversight includes proper reporting of site revenues, preparation of financial projections, invoicing to sponsors and CROs, and accounts receivable collections. You'll share best practices with other Velocity site locations to raise the overall level of operational competencies across Velocity. Additionally, you'll ensure completeness, accuracy, and timeliness of Feasibility Questionnaires, CDAs, CVs, and essential regulatory documents from study start-up phase until site initiation.

## Required Qualifications

You'll need a Bachelor's degree at minimum, with an advanced degree suggested or equivalent clinical research experience. Most importantly, you must have 5+ years of clinical management experience or equivalent applicable experience in the clinical research industry.

Expertise in project management with demonstrated ability to successfully manage people and projects is essential. You'll need proactive problem-solving abilities and follow-through, knowledge of field organizational strategies, and the ability to adapt to a rapidly changing work environment. Successful decentralized team management and situational responsive decision-making are critical.

Extensive knowledge of clinical research and understanding of drug development processes is required. You must be knowledgeable about critical elements for success in clinical trials, with participation in and contribution to these activities. The ability to review protocols, programs, and assess project success is necessary.

Strong communication and presentation skills—both written and verbal—are essential. You must be able to establish and maintain positive relationships with Sponsors, team members, and internal stakeholders, and conduct effective presentations. You'll need working knowledge of MS Office suite, Clinical Conductor CTMS, and relevant CRM systems, with the ability to generate business correspondence, create forms, and generate reports as required.

Professionalism and integrity in all actions are expected, with demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility. Effective communication in English, both verbal and written, is required. You must be willing to travel up to 10% as needed for project team meetings, client presentations, and other professional meetings or conferences.

## Physical Requirements

The position involves prolonged periods of sitting at a desk and working on a computer. You must be able to lift up to 15 pounds at times.

## Benefits

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

For talented candidates who perform at a high level, Velocity invests to support career advancement and reward performance. This position offers the opportunity to make a meaningful impact on bringing innovative medical treatments to patients while advancing your career in clinical research.