Description
The Clinical Research Program Lead (CRPL) is a senior clinical research professional responsible for the operational logistics and coordination of research and/or research intervention projects under the direction of the principal investigator (PI). The encumbered has advanced knowledge and understanding of the planning, implementation, and management of research operations. Responsible for planning and management of the approval, implementation and conduct of research protocols and/or research interventions from planning through completion and reporting, ensuring that the processes, integrity and quality of the research are assessed and maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, organizational Policy & Procedure, and research protocols. Serves as a resource for inquiries and maintains communication with the Investigators, participants, sponsors, IRBs, DSMBs and other research related entities. Functions as a departmental resource in research operations. Works independently and may mentor, train and direct the work of Clinical Research Coordinators/Assistants/Interns. Demonstrates expert clinical, organizational, and communication skills and functions as resource regarding the clinical research and/or grants process. Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. Facilitates the preparation of Institutional Review Board applications for research proposals, develops and manages budgets and coordinates grant applications, progress reports and regulatory documentations submissions as required by the sponsor. The position will interface with faculty, collaborators, and administration to report project progress and trouble shoot barriers. Outstanding communication and organizational skills, the ability to proactively manage challenges, and strong attention to detail are required. The individual is supervised by a Clinical Research Program Manager/Director or the Principal Investigator.
Qualifications

MINIMUM EDUCATION

BA/BS degree in science, technical, or health-related field with > 5 year relevant experience MS degree with 3 years relevant experience; Doctoral degree with > 2 years of relevant experience .

MINIMUM WORK EXPERIENCE

2-4 years of clinical research experience or an equivalent combination of relevant education and/or experience managing NIH or industry sponsored clinical research projects. Supervisory/management experience in related job function. Preferred/Desired Experience: Pediatrics experience preferred. .

Please refer the Job description for details