What are the responsibilities and job description for the Site Director - 238308 position at Medix?
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 :
Additional Notes :
