Director Clinical Research Operations

$111,779 - $201,427/Yr

MedStar Health - Washington, DC

Full-time - Senior

Washington, DC

Hospitals

About the position

MedStar Health Research Institute is seeking a highly qualified Director of Clinical Research Operations to lead our Cardiology research team located at the MedStar Washington Hospital Center in Washington, DC. This pivotal role involves the comprehensive oversight and coordination of clinical trials managed by the Clinical Research Network (CRN) Contract Research Organization (CRO). The Director will be responsible for ensuring that all aspects of clinical trial operations are executed efficiently and in compliance with regulatory standards. This includes overseeing chart review processes and follow-up activities within the data coordinating center, ensuring that all data collected is accurate and reliable. In addition to managing clinical trials, the Director will also provide management and database support, leveraging the services of the Angiographic Core Lab and the Platelet Center. This role requires a strategic thinker who can navigate the complexities of clinical research while fostering collaboration among various stakeholders. The Director will play a crucial role in enhancing the quality and efficiency of clinical research operations, ultimately contributing to the advancement of cardiology research and patient care. The ideal candidate will possess a strong background in clinical research, with a focus on phases I-IV trials, and will have a deep understanding of the regulatory landscape, including FDA, ICH, and GCP guidelines. This position offers a unique opportunity to lead a dedicated team in a dynamic research environment, making significant contributions to the field of cardiology.

Responsibilities

• Oversee and coordinate CRN clinical trials managed by the CRN CRO.
• Manage chart review and follow-up activities in the data coordinating center.
• Provide management and database support using the services of the Angiographic Core Lab and the Platelet Center.
• Ensure compliance with FDA, ICH, GCP, and other regulatory functions throughout the clinical trial process.
• Collaborate with various stakeholders to enhance the quality and efficiency of clinical research operations.

Requirements

• Master's degree in Healthcare field or life sciences required.
• 10+ years' experience in phase I-IV clinical trials and knowledge of the medical field required.
• Excellent working knowledge of FDA, ICH, GCP, and other regulatory functions required.
• Strong knowledge of CRO structure and processes required.
• Previous management experience required.
• Proficiency with basic computer programs and exposure to Access, Visual Basic, and other relational databases required.
• Excellent writing skills and ability to communicate effectively with staff and management.