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Monitor Veterinary Clinical Studies (Remote)

knoell USA LLC
Roseland, NJ
  • Posted: over a month ago
  • Full-Time
Job Description
 

Job Title: Monitor Veterinary Clinical Studies

Location: Option to work remote or knoell office (Garnet Valley, PA; Research Triangle Park, NC)

Group: Animal Health


Company Background
 
knoell is a global company headquartered out of Germany that researches, processes and evaluates scientific data across all scientific specialties. Our vision is to be the trusted industry leader in worldwide regulatory solutions.  We compile registration dossiers and submit them to national and international authorities. The size of our company allows us to act as a full service provider and assemble a team of the required size and expertise to serve clients in agrochemical, biocides, industrial chemicals, product safety, veterinary medicine and medical devices.  

At knoell Animal Health, LLC, you are part of an international team of more than 45 Animal Health experts including specialists in pharmaceuticals, biologics, feed additives, toxicology, safety, chemistry and clinical studies.

We support manufacturers of animal health products with our extensive expertise at every point of the product life cycle. Our animal health experts support our clients in gaining access to global key markets including Europe, North & South America and Asia.

Position Summary

The Monitor Veterinary Clinical Studies acts as a key member of the clinical studies team, coordinating stakeholder communication and ensuring the quality of the data produced. The Monitor is responsible for the verification and compilation of data; communication with Sponsors, third party vendors, and other team members; and visiting study sites. 

The successful candidate will possess strong knowledge of VICH GCP regulations and will have experience monitoring multi-site, pivotal clinical studies. As a member of the Clinical Development Team the position holder is involved in the planning, conduct and reporting of Veterinary Clinical Studies conducted in compliance with VICH Topic GL9 (GCP), Guideline on Good Clinical Practice:  (CVMP/VICH/595/98 – Final, or CVM GFI #85 (VICH GL9) Good Clinical Practice).

This position will have strong communication, detail-orientation, and the ability to manage multiple projects in a client-driven environment. 

Essential Functions

  • Participate in VICH Good Clinical Practice (VICH GCP) veterinary clinical studies in the role of Monitor. 
  • Compile and peer-review Standard Operating Procedures, clinical study Protocols and Study Reports, data collection sheets, general forms, and other associated documents using knoell Animal Health templates, according to appropriate guidelines and in accordance with training and competency.
  • Conduct Monitor visits at study sites (including commercial farms, veterinary practices, kennels, stables, laboratories, contract research organizations, etc.) to recruit, qualify and train study participants, review the performance of the study and verify the data collected. 
  • Compile Monitor reports of visits to report on the progress of the study and obtain corrective actions as necessary. 
  • Provide oversight of regulatory studies (performed in compliance with Good Laboratory Practice (GLP) or GCP or other applicable standards) conducted by third parties related to the development of veterinary vaccines or pharmaceuticals, in the role of Sponsor Representative.
  • Enter study data and/or Company administrative data into spreadsheets and databases.  Verify this data when applicable by using established quality control techniques.  Analyze data using simple functions, including statistical features, to prepare tables, graphs, charts and reports.
  • Adhere to the following in all appropriate aspects of the position:
    • Maintain documentation, records, data in general adherence to applicable standards, internal quality systems and policies of knoell Animal Health. 
    • Communicate with clients and other external bodies in line with company policy. 
    • Conduct other work suitable to abilities, training, experience and position, as requested. This may include administrative tasks and assistance to other Company personnel.  

Requirements:

  • Associate’s degree (or equivalent) required, preferably in animal science, biology, or related life science/medical fields. 
  • Minimum of 1 year of experience in the animal health field.
  • Experience with GCP and/or GLP studies preferred.
  • Experience working in private veterinary practice is a plus.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization and the client’s organization, if applicable.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to work independently with limited oversight.
  • Ability to identify and solve problems in a strategic manner.
  • Ability to be proactive and anticipate the dynamic needs of clinical studies.
  • Ability to travel up to 30% of time. Travel may be intermittent, and can usually be planned.

Benefits:

At knoell Animal Health, LLC you will be working in a professional, fast-growing, international organization. We offer a competitive compensation package teamed with comprehensive benefits. 

We are an Equal Opportunity Employer and do not discriminate on the basis of 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.

knoell USA LLC

Address

Roseland, NJ
07068 USA

Industry

Healthcare

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