Leads and manages the clinical trials research programs and initiatives at Boys Town National Research Hospital. Oversees the planning, execution, and reporting of clinical trials and studies to ensure compliance with regulatory guidelines and industry standards. Collaborates with cross-functional teams, including medical professionals, scientists, regulatory affairs, and data management, to drive successful clinical research projects.
MAJOR RESPONSIBILITIES & DUTIES:
- Develops and implements the clinical research strategy and operational plans aligned with the organization's goals and objectives.
- Leads and mentors a team of clinical research professionals, including clinical research associates, coordinators, and project managers.
- Manages the design and protocol development of clinical trials, ensuring adherence to ethical principles, safety guidelines, and regulatory requirements.
- Oversees the preparation and submission of clinical trial applications to regulatory authorities, such as the FDA and/or other relevant bodies.
- Collaborates with medical experts and investigators to identify and select suitable clinical trial sites and investigators.
- Develops and facilitates an internal monitoring program to review data management, identify risks, reduce potential for risk to Boys Town, the research department and research subjects.
- Maintains reporting standards for adverse events in accordance with regulatory and industry guidelines and compliance.
- Reviews and develops department operating procedures to ensure quality implementation of research protocols, ensure the integrity of the data and the safety of research subjects.
- Implements correction action as needed to meet research outcomes for trials. Prepares and presents regular updates and reports on clinical research progress to senior management and stakeholders.
- Collaborates with the biostatistics team to perform statistical analysis of trial data and support the interpretation of study results.
- Collaborates with the medical writing team to prepare clinical study reports, publications, and other regulatory documentation as needed.
- Stays informed about advancements in clinical research methodologies, technology, and regulations to enhance the organization's research capabilities.
- Manages the clinical research budget, resource allocation, and vendor selection as applicable.
KNOWLEDGE, SKILLS, AND ABILITIES:
- Proven leadership skills with the ability to effectively manage and motivate a team.
- Excellent communication and interpersonal skills to collaborate with internal and external stakeholders effectively.
- Strong problem-solving and decision-making abilities to address complex clinical research issues.
- Detail-oriented and organized to ensure compliance and data integrity.
- Ability to handle multiple projects simultaneously and prioritize tasks accordingly.
- Proficiency in relevant software applications and clinical trial management systems.
REQUIRED QUALIFICATIONS:
- Advanced degree (Ph.D., Pharm.D., M.D., or R.N.) in a medical sciences or life sciences-related field required.
- Minimum eight years of experience in clinical research, including significant experience in clinical trial management and leadership roles required.
- Thorough understanding of the drug development process and clinical trial phases (Phase I-IV) required.
- Collaborative Institutional Training Initiative (CITI) certification within 30 days of transfer or hire required.
- Other Duties: This job description incorporates the essential functions and duties required for this position. However, other duties may be required and assigned at times and as determined by a supervisor in order to meet the needs of the organization.
- Serves as a role model in carrying out activities and behaviors that reflect the values and principles of the Boys Town mission.
PHYSICAL REQUIREMENTS, EQUIPMENT USAGE, WORK ENVIRONMENT:
- Position is relatively sedentary in a normal office administrative environment involving minimum exposure to physical risks. Will use office equipment such as a computer/laptop, monitor, keyboard, and a general workstation set-up.
