Essential Duties and Responsibilities

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Act as the primary point of contact with internal administrative functions to include Procurement, Finance, and Legal to enable the execution of the clinical activities.
• Serve as the main document control coordinator ensuring proper version control during critical document reviews and subsequent publication.
• Assist with oversight of outside vendors, consultants, and clinical research organizations (CROs) and coordinate the needed interactions with internal vendors.
• Maintain, and continuously improve clinical veterinary operation functions.
• Aid in developing additional tools and refining processes to ensure all clinical veterinary projects run efficiently and effectively.
• Ensure that assigned projects are properly monitored, and that data are accurate and collected uniformly among the various investigative study sites.
• Participate in regular meetings, follow-up on assigned tasks and issues, and transfer of important information to management.
• Assist in the coordination of all study activities, including start up, Investigator training, study conduct, site monitoring and close out.
• Assists Clinical Development with tasks required to conduct clinical veterinary studies during all phases of an assigned project or program.
• Assists in the authoring of clinical study protocols, amendments, deviations, and final reports as required.
• Utilize industry best practices, techniques, and standards throughout entire project execution for the timely completion of all clinical studies.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Bachelors' degree in STEM is required.
• Minimum 2 years as a clinical study coordinator/monitor in the pharmaceutical industry; preferably in the veterinary pharmaceutical industry.
• Experience conducting/monitoring studies to Good Clinical Practice and/or Good Laboratory Practice standards.
• Experience with electronic data capture platform/ eClinical software.
• Experience working with Clinical Trial Management software platforms.
• Ability to multi-task and successfully handle multiple priorities simultaneously.
• A growth mindset with a proactive approach to challenges is a plus.
• Proven proficiency in Microsoft Office and use of cloud-based applications. Proficiency in MS Word and scientific writing is a must.
• Strong written, verbal communication and interpersonal skills with employees at all levels of an organization.
• Strong strategic and critical thinking skills; including problem solving.

Physical Environment and Requirements

• Ability to travel overnight up to 25%.
• Ability to be able to work remotely and have reasonable infrastructure to access the internet.
• Employee must be able to occasionally lift and/or move up to 15 pounds.

Expected Salary Range :

$91,300-$108,000

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

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