Clinical Studies Coordinator - Mars Veterinary Health

Mars Veterinary Health Clinical Studies Coordinator

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Summary and Qualifications:

As part of the Mars Petcare family of businesses, Mars Veterinary Health is a global network of veterinary practices made possible by 75,000 Associates who care for millions of pets across nearly 3,000 clinics in more than 20 countries each year. We are committed to leveraging our reach to make a long-term positive impact on people, pets, and the planet and know our Purpose A BETTER WORLD FOR PETS starts with the people who care for them. We strive to offer unparalleled veterinary care for pets by first and foremost enabling and empowering our Associates to do what they love, whether in primary, specialty, and emergency care or management and leadership.

Role Purpose:

The MVH Clinical Studies Coordinator (CSC) is a specialized studies professional working with and under the direction of the MVH Director of Clinical Studies (DCS). While the DCS is primarily responsible for the conduct and management of the clinical studies that MVH participates in, the CSC supports, facilitates, and coordinates the daily clinical study activities and plays a critical role in the conduct of the studies. By performing these duties, the CSC works with the DCS, the MVH Clinical Studies Accounting (CSA) group, the study sponsors and the MVH study sites to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Essential Responsibilities and Tasks:

• Interfaces with MVH CSA team regularly to ensure work being completed by clinical study sites is reflected in financial reports and invoices to sponsors. Regularly also ensures financial remuneration to MVH clinical study site investigators and technicians is being properly communicated and delivered. Assists the DCS in development of study budgets via Scope of Work (SOW) materials with the help of the MVH Pricing/Coding and CSA teams. Assists the DCS in development of reports reflecting study case accrual and financial reports (with the help of MVH CSA team) within and across studies compared to pre-study budgets and timelines. Assists in study post-mortem reviews and generation of study site/investigator/technician reviews and grading to help delineate best site/investigator/technician teams for subsequent studies.
• Coordinates with DCS to ensure clinical studies and related activities are performed in accordance with sponsoring agency and MVH policies and procedures. CSC will be the primary day-to-day liaison for the MVH clinical study sites. CSC will have weekly conference calls with DCS to discuss current, finishing, and new possible studies. Assists the DCS and WoofU team in development of materials and tools necessary to appropriately train individuals involved in the conduct of the studies related to (but not limited to) protocol requirements, schedule of visits, execution of study plan, GCP (Good Clinical Practice), etc. Maintains documentation of training. Cooperates with compliance and monitoring efforts related to clinical studies and reports instances of noncompliance to the DCS and sponsors. Coordinates and facilitates monitoring and auditing visits with MVH study sites. Notifies DCS and CMO of external audits by FDA. Collaborates with DCS and study sites to respond to any audit findings and implement approved recommendations as necessary. Assists DCS & MVH CSA in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training logs.
• Attends local or semi-local study site and/or investigator meetings (e.g., sponsor site initiation visits at West LA or similar local to semi-local sites).
• Establishes and organizes study files, including but not limited to, study and/or regulatory binders, study specific source documentation and other materials. Reviews and develops a familiarity with the sponsor contracts and conditions. Works with the DCS to assure that the study is in compliance with all terms and conditions, including but not limited to training, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions. Reviews and develops a familiarity with the study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, etc.
• Works with the DCS to develop and implement enhanced study recruitment strategies (e.g., primary care DVM and/or technician emails, faxblasts, social media, websites, etc.) in accordance with sponsor and MVH policies and procedures. Works with MVH study sites to maintain study timelines, adequate inventory of study supplies, handling investigational drugs/devices, following sponsor protocol and/or Drug/Device Accountability standards and documentation. Helps MVH study sites complete study documentation and files in accordance with sponsor requirements and MVH policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, etc.
• Maintains effective and ongoing communication with DCS, sponsor, MVH study sites and MVH CSA team during the course of the study. Assists sponsor and DCS in preparation and/or dissemination of any modifications to the scientific protocol in accordance with Federal, sponsor and/or MVH regulations, policies, and procedures. Works with the DCS and MVH CSA to manage the day-to-day activities of the studies including problem solving, communication and protocol management. Promotes the ethical conduct of studies by reporting good faith suspicions of misconduct to the DCS and CMO. Assists the DCS in submission of accurate and timely closeout documents when applicable to sponsoring companies & Federal agencies in accordance with Federal regulations and sponsoring agency as well as MVH policies and procedures. Arranges for secure storage of study documents that will be maintained at the MVH study sites and/or on site at the MVH support office according to sponsor policy or for the contracted length of time, whichever is longer.
• Other job duties as assigned.

Special Working Conditions:

• Ability to work at a computer for long periods of time.
• Project timelines and work volume/deadlines may often require more than 40 hours per week to complete essential duties of this job.
• Must have mental processes for reasoning, remembering, mathematics and language ability (reading, writing, and speaking the English language) to perform the duties proficiently.
• Ability to carry out instructions furnished in written, oral, or diagram form and to solve problems involving several variables.
• Ability to stand, walk, stoop, kneel, crouch, and climb as well as manipulate (lift, carry, move) up to 50 pounds.
• Requires good hand-eye coordination, arm-hand-finger dexterity with the ability to grasp, and visual acuity to use a keyboard and operate necessary equipment.
• The noise level in the work environment is normally moderate.
• Environment where pets are present.

Experience, Education and/or Training:

• Meet one of the following requirements:
  • a graduate of a two-year AVMA-accredited RVT (Registered Veterinary Technician) or VT (Veterinary Technician) program
  • a graduate of a California-approved RVT program
  • a graduate of a two-year curriculum in veterinary technology that is not accredited by the AVMA or approved by the Veterinary Medical Board with 18 months practical experience under the direct supervision of a licensed veterinarian
  • have a Bachelor of Science or Bachelor of Arts degree in a field or major related to animal health technology and have 24 months of practical experience under the direct supervision of a licensed veterinarian
  • have 3 or more years of experience managing clinical trials or a combination of graduate level education and managing clinical trials in a veterinary and/or human care setting.
• Prior experience in an animal or human healthcare setting is required, familiarity with GCP and VICH is preferred.
• CCRC, CCRP, and/or CCRA is preferred.
• Strong written and verbal communication, with the ability to work with many types of stakeholders (internal and external), is required.

Compensation: B4-DNE

What We Offer The Good Stuff:

• Competitive salary with paid time off & holidays so you can spend time with the people you love.
• Medical, dental, and vision insurance for you and your loved ones.
• Fertility and family-building assistance.
• Paid Parental leave.
• Practice Paid Basic Life Insurance.