Job Description

Summary:

The Clinical Research Site Director is responsible for managing the overall business and clinical operations of the site to ensure that appropriate targets are met. The Site Director is responsible for managing the site’s 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 site’s 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 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 site's 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 fulfill any site resource needs which are necessary to successfully conduct and/or recruit research studies.
• 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 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.
• Ensure completeness, accuracy and timeliness of Feasibility Questionnaires, CDAs, CVs and essential regulatory documents from study start-up phase until site initiation

Required Skills/Abilities:

• Minimum 7 years experience in the clinical research field - ideally looking for an individual who has worked at a larger practice or practices
• Minimum 5 years experience in leadership/management role
• Experience establishing new sites and managing multiple sites locations preferred
• Expertise in project management demonstrated ability to successfully manage people/projects. Proactive problem-solving abilities and follow-through
• Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive Sponsor, team members and internal relationships. Ability to conduct effective presentations.
• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
• Ability to communicate effectively - looking for someone positive and even keeled
• Willingness travel, as needed, for new site development/oversight, project team meetings, client presentations and other professional meetings/conferences as needed.
• Other duties as assigned

Additional Notes:

• Open to reviewing relocation candidates with the required experience and knowledge

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.

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