Posted in Other 2 days ago.
Location: Burlington, Vermont
The University is especially interested in candidates who can contribute to the diversity and excellence of the institution. Applicants are encouraged to include in their cover letter information about how they will further this goal.
Coordinate clinical research protocols for the Vaccine Testing Center (VTC) in the Department of Microbiology and Molecular Genetics. Collaborate with researchers on protocol development, planning and implementation. Prepare and maintain all study regulatory documents for submission and continuation to applicable Institutional Review Board(s), study monitors and regulatory authorities. Manage study documentation to ensure compliance with local and federal regulations including the US Code of Federal Regulations and The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines. Act as primary point of contact for issues arising related to routine operations in an international clinical trial, including events pertaining to subject safety. Work with international collaborators including members of clinical, regulatory, laboratory and data management teams, to asses timely and accurate reporting of events. Work collaboratively with international study staff to coordinate and conduct QA/QC of research study data and data entry in databases. Compile and analyze study data. Prepare reports and presentations for annual reviews and publications. Design and maintain responsibility and oversight of study-specific Quality Management Plans. Interface directly with collaborators and field staff at international study field sites as well as with domestic research partners, research sponsor representatives, laboratory staff, regulatory office staff, and others.
Bachelor's degree with a scientific background and three to five years' experience as a clinical research coordinator or related experience required. Demonstrated ability to work effectively as part of an international team and with study subjects in a clinical research environment. Effective interpersonal communication skills and time management skills essential. Ability to work with remote supervision. Training and/or certification as a clinical research coordinator, such as Good Clinical Practices (GCP), or the ability to obtain.
Experience in large-scale international clinical trials desired.
A six-month probationary period is required
Contingent on continued funding
COM Microbio & Molec Genetics/55120
US Ecology, Inc.
US Ecology, Inc.
Global Partners LP