Eximia Research is a fully Integrated research sites network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). Our premier, multidisciplinary wholly owned research sites located across country and known for excellent trial execution, rapid subject recruitment/enrollment and delivery of a quality data.
Summary: Join us at Eximia Research Network as we continue to grow, the Clinical Research Site Director is responsible for the management of study team and the overall coordination and successful execution of all aspects of the assigned clinical trial(s) in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs.
Key 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 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 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.
Manage facility and IT needs to ensure smooth and efficient