DIRECTOR, CLINICAL SITE

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 Clinical Site Director is responsible for managing the overall business and clinical operations of the site to ensure that appropriate targets are met. The Clinical Site Director is responsible for managing the sites annual and forecast operating budgets and for the efficient coordination, organization and conduct of clinical trials. The Clinical Site Director oversees and manages all aspects of the clinical trial process including study feasibility, clinic staffing, patient recruitment, study conduct and regulatory compliance. The Clinical Site Director is responsible for ensuring the health and safety of study patients and staff.

Responsibilities :

Duties / Responsibilities :

• Work with the Senior Director of Clinical Operations to manage the operational budget and meet / exceed the sites financial, operational, and study-specific targets.
• Maintain complete (24 / 7) control over the overall operations and management of clinical research trials at the site
• Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business and growth plans
• Oversee the implementation and maintenance of Velocity quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs and Velocity SOPs
• Work with the Medical Director to address any study and / or clinical quality related
• Ensure timely and appropriate communications occur with Sponsors, CROs and IRBs as necessary
• Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and / or recruit research studies.
• Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments / modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
• Manage the performance of site staff members, delegating appropriate and challenging assignments to encourage growth, development and responsibility. Responsible for ensuring the ongoing training needs of site staff members are met.
• Responsible for the assurance of all site staff complete required trainings.
• Establish and communicate performance expectations and guidelines to site staff
• Facilitate annual performance evaluation process with site staff.
• Identify and manage issues, concerns and problems related to staff conduct and
• Identify and build relationships with outside medical practices, pharmacies, and other health care professionals / organizations to aid in the patient recruitment process.
• Conduct business development activities on behalf of the site and Velocity with sponsors, CROs, CRAs and any third-party study vendors, as appropriate.
• Responsible for overseeing the proper reporting of site revenues, preparation of financial projections, invoicing to sponsors / CROs, and A / R collections.
• Share best practices with other Velocity site locations with the goal of raising the overall level of operational competencies at Velocity.
• Ensure completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation

Qualifications :

Required Skills / Abilities :

Education and Experience :

Physical Requirements :

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.