The Clinical Research Associate (CRA) will support the execution of veterinary clinical studies from concept to completion in accordance with applicable SOPs, FDA regulations, and recognized standards for clinical research.Reports to:
Vice President, Clinical Operations Essential Functions:
- Assumes project management responsibilities for assigned clinical studies; participates in project planning and budget development
- Collaborates with client business partners on study-related work to ensure that study objectives are met
- Prepares status update reports on assigned clinical studies; tracks enrollment and subject progress through study; liaises with finance to support site budget tracking and payment processing
- Participates in investigator selection, recruitment, and training; interacts with study sites during study conduct and evaluates performance; identifies opportunities for training
- Assumes in-house monitoring of study records and data as required by GCPs; performs onsite monitoring at local study site(s) in compliance with GCPs to support study success
- Identifies issues related to the project and evaluates potential causes; proposes and implements solutions when necessary, elevates issues as needed
- Plans, creates, and delivers presentations of clinical research study information
- Supports quality and data management activities
- Provides input on departmental decisions related to process and procedures; reviews and updates SOPs as required
- A minimum of 2 years direct experience in clinical research, CRA certification desired
- Experience in veterinary practice environment a plus
- Strong computer skills with Microsoft Office applications
- Experience with EDC and CTMS
- Knowledge of FDA regulations and processes with a solid understanding of clinical research and GCPs
- Excellent, grammatically-correct , and professional communication skills, both oral and written
- Ability to display commitment to consistently producing high quality work
- High degree of independence and initiative; exceptional time management and organizational skills; ability to reorganize priorities to meet changing business situations
- Strong interpersonal skills with the ability to influence others in a positive and effective manner, ability to work in a cross-functional team environment
- Demonstrated ability to contribute to a continuous learning and process improvement environment
- Sound analytical and problem-solving skills
- Ability to multi-task, act with a consistent sense of urgency, and demonstrate acute attention to detail
- While not having direct supervisory responsibility for any employees, CRAs do collaborate with client business partners on study-related work to ensure that study objectives are met.
- Work is primarily sedentary in nature, but may require occasional local driving (post office, copy center, etc.).
- Lifting light boxes and/or equipment (less than 20 pounds) may be required.
- Work area is adequately heated, lighted, and ventilated.
Occasional travel may be required. Location
: Rochester, NYContact
: Venkata Giri
The best telephone number to reach me is 732-276-9940 Ext: 325. I appreciate if you forward your updated word formatted resume at /email@example.com\ for review before we speak.