Clinical Research Manager Emergency Med

Grade: T28

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 salary structure.

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Summary:

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).

Founded in 1901 as Pennsylvania’s first co-educational medical school, the Lewis Katz School of Medicine has attained a national reputation for training humanistic clinicians and biomedical scientists. The school attracts students and faculty committed to making a difference in patient care, research, education and public service — at home and across the globe. 

The Lewis Katz School of Medicine at Temple University has experienced dramatic growth in the breadth and scope of its research enterprise over the past decade. As part of its strategic plan, our researchers and scientists have been responsible for ground-breaking advancements in areas across the scientific spectrum, including: Cancer Biology, Cardiovascular and Thrombosis, Cell and Developmental Biology, Clinical Lung Research, HIV, Immunology and Autoimmunity, Metabolic Syndrome and Diabetes, Neuroscience, Substance Abuse, Translational Medicine and more.

Essential Functions:

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.

Benefits of working at Temple University include:

Hybrid Work Arrangement

Great Benefit package

Generous time off 

Parental Leave

Tuition Remission

Dynamic Workforce

Click here to learn more about the benefits of working at Temple University.

Required Education & 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.

Preferred:

*Master’s degree

Required Skills & 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.

This position requires a background check.

This is a grant funded position.

Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.

Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.

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