Clinical Research Associate II (Animal Health)

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, subject to applicable law.

Our Animal Health Research & Development team works tirelessly to invent solutions to improve the health and well-being of animals. Our state-of-the-art research facilities provide an environment of innovation that enable us to create breakthrough science changing the way we approach animal health challenges.

The primary function of the Clinical Research Associate position is to monitor clinical laboratory and field studies that will support the regulatory approval of new companion animal and livestock products. These studies must be conducted in compliance with the requirements of Good Clinical Practice.

The Clinical Research Associate acts primarily as the study monitor and is the primary contact with study sites and investigators. In collaboration with the Clinical Research Manager (CRM), designs, conducts and reports clinical studies according to GCP.

Specifically, the CRA has the following tasks and responsibilities:
  • Assist the CSTL with the selection of study sites, Investigators and laboratories.
  • Train the Investigator(s) and other study participants, as appropriate, for the study protocol and Good Clinical Practice.
  • Conduct monitoring visits and maintain communication with investigators and other study personnel.
  • Prepare study documentation such as notebooks and Case Report Forms, in collaboration with Data Manager.
  • Organize the shipment and submission of study materials and samples as appropriate.
  • Apply for the necessary local study permits and licenses in close collaboration with the CRM.
  • Maintain an accurate and complete log of all contacts with the investigator and other study participants and ensure that deviations from the protocol are documented.
  • Ensure that adverse events are documented and reported according to the applicable procedures and time lines.
  • Review the raw data and ensure that illegible or missing data are explained and/or corrected.
  • Organize translation of study documents as appropriate.
  • Enter data into an electronic data set and/or check correct data entry.
  • Ensure that data queries are answered and documented adequately.
  • Check the correct storage, dispensing and disposal of the study products and its documentation.
  • Maintain inventory of (I)VP, CP and test materials, as appropriate.
  • Participate in the preparation of the Study Documentation File (SDF).


In addition, the CRA:
  • Performs quality control inspections of study protocol, study documentation and reports as appropriate.
  • Performs User Acceptance Tests of electronic CRFs.
  • A more experienced CRA may act as Clinical Study Team Leader (CSTL) for certain small scale studies or studies with a standard design. This includes the responsibility for design, budget, protocol and report of the study.


Education Minimum Requirement:
  • A Bachelor degree or equivalent in a relevant biological field


Required Experience and Skills:
  • A minimum of two 2 years of experience in clinical research or equivalent role.
  • Experience in a clinical study related role.
  • Good written and oral communication skills.
  • A strong ability in scientific writing.
  • Proficient in MS Office applications and in EDC.


Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world's food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.

Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.

Who we are ...

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for ...

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
25%

Flexible Work Arrangements:

Shift:

Valid Driving License:
Yes

Hazardous Material(s):

Number of Openings:
1

Requisition ID:R146803