Senior Clinical Research Associate (remote/home-based position)

VetPharm, Inc. - Rochester, NY

Full-time | Part-time | Contract

Job Description:

The Senior Clinical Research Associate (sometimes called a Study Monitor) is VetPharm’s primary link to operations in the field. They are responsible for the quality, consistency, and accuracy of all data generated by the licensed veterinarians at the individual animal hospitals or clinics (study sites). They ensure that the experimental study compound is securely stored at each site, properly administered by the veterinarian, and accurately accounted for by the site staff. They track study subject (client-owned pet) enrollment and assist the individual study sites in meeting study timelines. If, in their opinion, any site fails to meet VetPharm’s exacting standards, the Senior CRA provides remedial training and other support to improve the site’s performance.

Throughout each study, the Senior CRA will verify individual study site compliance with VetPharm standard operating procedures (SOPs), the study protocol, study-specific SOPs, and the FDA/CVM’s Guidelines and Guidance Document No. 85 (VICH GL9) Good Clinical Practice (GCP). If any site is not compliant in any respect, the Senior CRA will decide what corrective action is warranted or, in certain instances, recommend the site for closure.

VetPharm’s Senior CRAs can be based in the company’s headquarters office in East Rochester, New York, or in any other area with regular and convenient airline connections. Their work, which combines auditing, quality control, and database administration, is primarily sedentary in nature and typically is performed at a desk or table, using a laptop computer or PC, telephone, and other customary office equipment.

As summarized above and described in more detail below, their primary activities are directly related to the business operations of VetPharm, which involve the management of veterinary clinical trials. Many of their responsibilities require them to make independent judgments regarding significant issues affecting the overall success of individual studies and/or the health and safety of individual participating animals.

The most likely career progression for a Senior CRA would be promotion to Project Leader and then to Clinical Trial Manager. Senior CRAs who exhibit strong planning, organization, and administrative abilities, professional and effective communication skills, and reliable, timely, and superior results will be prime candidates for promotion.

Reports to:

President and CEO

Key Interfaces:

Other CRAs

Chief Financial Officer

VetPharm administrative staff

Veterinary clinic staff participating in studies including, but not limited to, licensed veterinarians (DVMs or VMDs), licensed or registered veterinary technicians, and clinic managers and administrators

Study team leaders at sponsor pharmaceutical, nutrition, nutraceutical, and device companies (usually veterinarians with advanced degrees including PhD)

VetPharm subcontractors including clinical laboratories, computer system providers, biostatisticians, medical writers, and experimental study compound packaging, storage, and distribution companies

Essential Functions:

· Follows VetPharm’s study management process, which is a set of detailed procedures followed by all VetPharm personnel to ensure high-quality results and full regulatory compliance during the planning, implementation, and management of each clinical trial.

· Participates in the planning for each new study.

· Reviews and develops a thorough understanding of each new study’s protocol

· Assists in the selection of veterinarians to serve as study investigators in each clinical trial

· Contributes to the development and presentation of training programs for all study participants.

· Documents the progress of study subject enrollment against target and implements enrollment support measures as warranted.

· Continually assesses the performance of investigators and conducts remedial training as needed to maintain VetPharm standards.

· Assists in the development and delivery of training for new CRAs.

· Identifies, evaluates, and recruits veterinarians to serve as future study investigators.

Qualifications:

· A minimum of ten years of clinical trials monitoring experience (or equivalent) or ten years of clinical trial project management experience (or equivalent), or a combination thereof.

· Demonstrated commitment to excellence and continuous improvement

· Manifest dedication to superior client service

· Positive, “can do” attitude

· Excellent communication skills, both verbal and written, in English. High attention to proper grammar and correct spelling

· Advanced computer literacy in Microsoft Office (Outlook, Word, Excel, and PowerPoint)

· Potential for leadership. Accepts and gives constructive criticism. Requests and gives feedback whenever appropriate

· Ability to understand and discuss scientific and medical research documents

· Ability to develop, organize, and prioritize diverse and complex projects, as well as adapt to unforeseen changes in those projects

· Ability and willingness to travel within the continental United States as necessary to maintain study site performance

Supervisory Responsibility:

Oversees, coordinates, supports, and evaluates the performance of investigators and site staff participating in each study. Senior CRAs typically are not assigned to more than two studies at any one time. Each study usually will have a minimum of four sites but could have as many as thirty. Each site usually assigns one or two veterinarians and one to four site staff to a study.

Qualified individuals should email the President their resume and a letter describing:

1. How this position would help them advance toward their personal goals,

2. How they would support VetPharm's reputation for error-free data, and

3. How their presence on the team would enhance VetPharm’s culture.

Job Type: Full-time or part-time, independent contractor position

Compensation: $75 to $100 per hour, depending on experience and performance

Job Types: Full-time, Part-time, Contract

Salary: $75.00 to $100.00 /hour

Experience:

  • monitoring: 10 years (Required)

Education:

  • Bachelor's (Required)

Required travel:

  • 50% (Required)

Contract Length:

  • Varies

Contract Renewal:

  • Likely

Full Time Opportunity:

  • Yes

Additional Compensation:

  • Bonuses

Work Location:

  • Fully Remote

Schedule:

  • Monday to Friday