Principal Specialist: Study Management
Apply NowCompany: Clingroup
Location: Brookings, SD 57006
Description:
Departmental Objective
To efficiently conduct research in compliance with the Quality Management System, the Animal Care and Use Program, project budgets, and timelines
To expand and improve the site research activities through innovation, development, and customer focus.
Primary Job Purpose
Serve as lead support to a Principal Specialist: Study Management as needed on studies. This position is responsible for monitoring animal health status, performing and coordinating study events, and reviewing and approving study documentation as necessary throughout the study. This position will have group leader responsibilities, assist other study investigators, and support staff as required.
Job Specific Duties and Responsibilities
Overall responsibility for the protocol development, technical conduct, and organizational aspects (start -finish) of GCP studies
Preparing, reviewing and approval of Sponsor clinical study protocols and data capture forms (DCFs)
Preparing study specific Clinvet IACUC protocols and IBC assessment
Organizing/coordinating pre-study meetings
Providing technical directions and guidance to each study participants in responsibilities and
accountabilities
Participating key clinical activities (such as pre-study room/pen walk-through, arrival infections, IVP administration, challenge, necropsy)
Providing study protocol and DFC training, critical disease training, Biosafety -Biosecurity-zoonotic disease biosecurity trainings as required
Ensuring effective communication with the Sponsor, QA, and other test sites/sub-contractors during the conduct of the study
Collaborating with RTI Laboratory to ensure timely submission of quality clinical samples and timely completion of laboratory tests and inventory of retention samples per study protocol
Collaborating with ClinData team to ensure timely delivery of DCFs for data Entry and analysis per study protocol
Assisting/hosting regulatory and sponsor inspections/audit and addressing regulatory inspection and QA audit findings including plan of actions/corrections
Prepare/review/Update clinical SOPs
Establishing professional network to support business development
Qualification, Training and Experience Requirements
PhD or MSc in life sciences or
Licensed Doctor of Veterinary Medicine (DVM) or
Post-secondary university degree in life sciences (e.g., BSc) and at least 5 years hands-on clinical animal research experience
To efficiently conduct research in compliance with the Quality Management System, the Animal Care and Use Program, project budgets, and timelines
To expand and improve the site research activities through innovation, development, and customer focus.
Primary Job Purpose
Serve as lead support to a Principal Specialist: Study Management as needed on studies. This position is responsible for monitoring animal health status, performing and coordinating study events, and reviewing and approving study documentation as necessary throughout the study. This position will have group leader responsibilities, assist other study investigators, and support staff as required.
Job Specific Duties and Responsibilities
Overall responsibility for the protocol development, technical conduct, and organizational aspects (start -finish) of GCP studies
Preparing, reviewing and approval of Sponsor clinical study protocols and data capture forms (DCFs)
Preparing study specific Clinvet IACUC protocols and IBC assessment
Organizing/coordinating pre-study meetings
Providing technical directions and guidance to each study participants in responsibilities and
accountabilities
Participating key clinical activities (such as pre-study room/pen walk-through, arrival infections, IVP administration, challenge, necropsy)
Providing study protocol and DFC training, critical disease training, Biosafety -Biosecurity-zoonotic disease biosecurity trainings as required
Ensuring effective communication with the Sponsor, QA, and other test sites/sub-contractors during the conduct of the study
Collaborating with RTI Laboratory to ensure timely submission of quality clinical samples and timely completion of laboratory tests and inventory of retention samples per study protocol
Collaborating with ClinData team to ensure timely delivery of DCFs for data Entry and analysis per study protocol
Assisting/hosting regulatory and sponsor inspections/audit and addressing regulatory inspection and QA audit findings including plan of actions/corrections
Prepare/review/Update clinical SOPs
Establishing professional network to support business development
Qualification, Training and Experience Requirements
PhD or MSc in life sciences or
Licensed Doctor of Veterinary Medicine (DVM) or
Post-secondary university degree in life sciences (e.g., BSc) and at least 5 years hands-on clinical animal research experience