$80K — $100K *
Reporting to the Vice-Chair of Clinical Research, the Clinical Research Manager will oversee the research operations within the Lewis Katz School of Medicine's Department of Emergency Medicine. The incumbent will create and refine strategies to enable the department's Principal Investigators to develop high-quality investigator-initiated clinical trials and research and perform industry-sponsored trials. Central to the position is meeting the reporting requirements of all external review organizations, most notably the Food and Drug Administration (FDA).
Responsibilities include: overseeing study implementation as defined in the study protocols; creating Standard Operating Procedures (SOPs) and/or guidelines and ensuring that SOPs, Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously; hiring, training and supervising research personnel, and developing roles, responsibilities, and expectations for staff; ensuring that each study meets care expectations and that studies are conducted in accordance with the specific protocol(s) as approved by the sponsor, study team, and in accordance with all regulatory organizations; may assist in study enrollments as necessary; planning and overseeing the formal evaluation of the program's performance toward its goals, and reporting on that evaluation to the Chairman, Administrator, and faculty; establishing processes and tools that foster communication and interactions between research collaborators, and ensuring that their needs are met; collaborating with health system senior leadership, TUSM Research Administration and LKSOM Clinical Research Administration in managing all clinical and operational aspects of each trial, and allocating resources as needed; and serving as the liaison with funding agencies from site initiation to close-out, and with the IRB to maintain regulatory compliance. In addition to study management, the Clinical Research Manager will assist Research Administration in establishing and managing industry trial budgets. The incumbent is also responsible for the development and implementation of processes that impact trials and/or program management. Performs other duties as assigned.
Required Education and Experience:
Bachelor's degree in a relevant field, and at least six years of related clinical research operations experience. An equivalent combination of education and experience may be considered.
Required Skills and Abilities:
*Demonstrated computer skills and proficiency with MS Office Suite programs.
*Demonstrated knowledge of GCP and ICH and the application to the conduct of clinical trials.
*Demonstrated expertise with IRB protocols and processes.
*Thorough understanding of cross-functional clinical processes, including clinical supply and data management.
*Strong analytical and problem-solving skills, with the ability to generate successful approaches to addressing issues that arise in the implementation of each study.
*Demonstrated organization and prioritization skills and ability to handle multiple tasks with competing deadlines.
*Exceptional interpersonal and collaborative skills, with the ability to interact effectively with a diverse constituent population in a constructive and engaging manner.
*Excellent written and verbal communication skills.
*Demonstrated supervisory skills.
*Strong attention to detail.
*Ability to travel to offsite locations that may not be accessible via public transportation.
*Ability to work evenings/weekends hours as needed.
*Master's degree in a related field.
This position requires a background check.
This is a grant funded position.
Valid through: 11/4/2021
$100K — $150K *
9 days ago