Position Details

Position Details

Diversity Statement The University is especially interested in candidates who can contribute to the diversity and excellence of the institution. Applicants are required to include in their cover letter information about how they will further this goal. Posting Summary

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 domestic and international clinical trials, including events pertaining to subject safety. Work with domestic and international collaborators including members of clinical, regulatory, laboratory and data management teams, to asses timely and accurate reporting of events. Work collaboratively with domestic and 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 domestic and international study field sites as well as with research partners, research sponsor representatives, laboratory staff, regulatory office staff, and others.

Minimum Qualifications (or equivalent combination of education and experience)

Bachelor's degree with a scientific background and three to five years' related experience required. Effective interpersonal communication skills and time management skills essential. Demonstrated ability to work effectively as part of domestic or international teams and with study subjects in a clinical research environment required. 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.

Desirable Qualifications

Other Information Special Conditions Non-standard work hours required, Bargaining unit position, External candidates must complete a 4-month probationary period, Contingent on continued funding, A probationary period may be required for current UVM employees FLSA Exempt Payband Min (Represents full-time (12 months, 1.0 FTE) equivalent salary. Must be prorated for jobs less than 12 months or 1.0FTE (Salary/12 x # of months x FTE)) 39000.00 Payband Max (Represents full-time (12 months, 1.0 FTE) equivalent salary. Must be prorated for jobs less than 12 months or 1.0FTE (Salary/12 x # of months x FTE)) 74100.00 Staff Hiring Band Hiring salary budgeted at low end to mid pay band Union Position Yes, UVMSU ($20 minimum hourly rate)

Posting Details

Position will be posted for a minimum of one week, after which it is subject to removal without notice.

Job Close Date (Jobs close at 11:59 PM EST.) Open Until Filled No

Position Information

Posting Number S4255PO Department COM Microbio & Molec Genetics/55120 Position Number 00026514 Employee FTE 1.0 Employee Term 12

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