Study Management Specialist

Clinvet USA is a global veterinary contract research organization (CRO) that conducts in vitro, preclinical, and clinical trials to evaluate animal health products' safety, metabolism, and efficacy. Clinvet is part of the Clinglobal group, an animal health-focused group of CROs dedicated to supporting innovation and product development. With a wealth of research experience, Clinvet has supported leading global animal health companies, small and medium-sized companies, and start-ups with their research and development programs since 1999.

We are actively seeking a Study Management Specialist to join our expanding Research Operations team. This position presents an exciting opportunity to expand and improve the site research activities through innovation, development, and customer focus.

Primary Job Purpose

As a Study Management Specialist you will manage, oversee, and take responsibility for all aspects of the overall conduct of studies while serving as the Study Investigator or Study Director. This includes group leadership responsibilities if a study is conducted by a group of individuals, and to act as an assistant to Study Directors/Investigators in the capacity of primary backup as assigned by management. This includes performing technical procedures and administrative tasks as needed.

Job Specific Responsibilities

• Serve as Investigator/Study Director as needed on studies as appointed by Test Facility Management.
• Primary role in drafting study proposals and budget development; protocol development, writing, editing and review; study report writing, editing, and review.
• Drafting and submission of research approvals to IACUC and IBC, including addressing any questions received from these committees.
• Ensure the health and welfare of the personnel involved in the study and the animals during the study through monitoring adherence to the biosafety manual and animal welfare policies.
• Overseeing the receipt, dispensing, and disposal of test articles or investigational veterinary products according to the study protocol, local regulations, and internal standard operating procedures.
• Overseeing the receipt, dispensing, and disposal of imported biological material according to the import permit and protocol requirements.
• Manage and oversee study phase outsourced to approved external laboratories/consultants/vendors.
• Provide guidance and training on studies to research and technical staff.
• Study sponsor interaction and effective and timely communication to study sponsor representatives, study monitors, and site management on study progress and results, including addressing any study related questions.
• Coordinate and/or participate in day-to-day research activities such as dose preparation, administration, observations, sample collection and other related research tasks.
• Serve as lead support to a Study Director/Investigator as needed on studies as appointed by test facility management. As lead support provide assistance in:
  • Study master file administration, including, but not limited to, the preparation and close-out of files, raw data reviews, and data management tasks.
  • Drafting study proposals, protocols, and reports.
    
  • Drafting research approval applications to IACUC and IBC
  • Coordinate study related activities and study setup
    
  • Participate in day-to-day research activities
• Coordinate and/or respond to quality assurance department, regulatory agency, and sponsor audits.
• Develop, validate, and execute novel study models.
• Identify and implement preventative measures in accordance with set instructions and procedures in cases where serious diseases are suspected.
• Control document development and review as required.

Qualification, Training, and Experience Requirements

• Licensed Doctor of Veterinary Medicine and 2 years' research experience, or
• Degree in Natural or Biological Science and 3-5 years' research experience, or
• Diploma in Veterinary Technology, Veterinary Medicine, or closely related field and 3-5 years' research experience, or
• At least 15 years' research experience for non-related degrees

Clinvet USA provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Salary : $80,000 - $100,000