Clinical Research Project Manager B/C

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Posted Job Title

Clinical Research Project Manager B/C

Job Profile Title

Clinical Research Project Manager B

Job Description Summary

The primary purpose of this position is to manage and oversee renal clinical research trials, specifically transplant and hypertension research portfolio ranging from observational and interventional phase I to IV trials, investigator initiated and industry sponsored trials that involve different disease states of varying complexities. Clinical Research Project Manager will provide expertise related to these trials, staff oversight, project management and leadership. The position involves planning, designing and overseeing the daily operations of the staff in order to successfully execute and operate the above research protocols (regulatory submissions and development of key study documents including protocol, consent, and CRFs) in accordance with all the regulatory organizations and sponsors, while maintaining best practices and procedures. He/She will work closely with the investigators and devise recruitment and retention strategies, and workflows for various studies to ensure enrollment goals are met. The position involves working closely with the pathology departments of multiple hospitals, and interact with other research institutions, industry sponsors and the NIAID to achieve the objectives of complex multi-center studies.

Job Description

Job Responsibilities

The position involves assessing the feasibility and performing the operational analysis of the novel research protocols, and conducting the startup work for these protocols by working closely with the business administration. He/She is responsible for overseeing the financial health of hypertension and transplant research protocols, facilitating the negotiations with the sponsors, and collaborate with the business administration for billing and invoicing activities.The Clinical Research Project Manager will provide staff oversight, project management, leadership and expertise associated with clinical trials for the Renal Clinical Research Unit consisting of projects in Transplant Nephrology and Hypertension.Clinical Research Project Manager B

• Will provide expertise related to these trials, staff oversight, project management and leadership. The position involves planning, designing and overseeing the daily operations of the staff in order to successfully execute and operate the above research protocols (regulatory submissions and development of key study documents including protocol, consent, and CRFs) in accordance with all the regulatory organizations and sponsors, while maintaining the best practices and procedures. He/She will work closely with the investigators and devise recruitment and retention strategies, and workflows for glomerular studies including the rare disease studies that are difficult to recruit. The position involves working closely with the p