"Research Coordinator / Research Coordinator Senior"

Job Description Summary

This position is a full-time Research Coordinator for a newly awarded Patient-Centered Outcomes Research Institute (PCORI) grant. The primary function is to facilitate, promote, and ensure good clinical practice in the conduct of the PCORI grant, especially project coordination and communication with the Sponsor and regulatory bodies. The position will also participate in and support study team meetings, assist other coordinators with study-related tasks, and support the Data and Safety Monitoring Board (DSMB) activities. The successful candidate will comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA, GCP and other regulatory standards. Must have experience with research clinical trials.

Please note, this position is contingent upon grant funding. Currently, this position is funded for 5 years.

This position is hybrid eligible after initial training period.

Research Coordinator Job Responsibilities

• Coordinate the conduct of PCORI grant according to protocol and in accordance with Good Clinical Practice (GCP)
• Assist clinical research coordinators in overseeing execution of project timelines as well as completion of study related activities delegated to research coordinator who provides study related support
• Complete relevant trainings
• Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing
• Coordinate, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., source documentation, case report forms, study and regulatory binders, and patient binders)
• Assist with data collection and maintenance of clinical trial databases and records in the Clinical Trials Management System (CTMS) in real-time
• Maintain the research study website
• Provide regular updates to the research team. Work as a part of the research team to maximize the efficiency and quality of research performed, including developing work instructions.
• Participate in and support study team meetings, including the Data and Safety Monitoring Board (DSMB) activities

Research Coordinator Senior Job Responsibilities

The Research Coordinator Senior will have the same duties as Research Coordinator but will include the following:

• This individual will work independently with minimal supervision
• Communicate and liaise with regulatory bodies, such as the IRB, ClinicalTrials.gov, and the PCORI program. This includes timely preparation and submission of regulatory documents (IRB amendments, ClinicalTrials.gov record updates, IDS, and progress reports for PCORI)
• Schedule and document meetings and reports: executive, ad board, and DSMB meetings; prepare PCORI and DSMB reports
• On behalf of the site, communicate with the Sponsor to share study-wide updates/issues with the Research Team's Program Manager and study team members who were not able to participate.

Qualifications

Research Coordinator

Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required, including 1-3 years of experience with clinical trials. Experience with PCORI grants is preferred. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of a research project including recruitment; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) ability to work as part of a team as well as independently; (5) detail-oriented and organized; (6) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.

Research Coordinator Senior

Bachelor of Science and 3 to 5 years of experience or equivalent combination of education and experience is required, including 1-3 years of experience with clinical trials. Experience with PCORI grants is preferred. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of a research project including recruitment; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) ability to work as part of a team as well as independently; (5) detail-oriented and organized; (6) possess working knowledge of the Title 21 Code of Federal Regulations (CFR), International Conference of Harmonisation (ICH) and Good Clinical (Research) Practice (GCP) Guidelines.

Job Location - City, State: Philadelphia, Pennsylvania

Department / School: Perelman School of Medicine

Pay Range: $44,500.00 - $63,610.00 Annual Rate