What are the responsibilities and job description for the Study Coordinator position at Northern Biomedical Research Inc?
Roles are posted at all levels and will be filled based on skills, certifications and experience.
Role Summary
The Study Coordinator will engage in assisting the Study Director group in the completion of study-related activities. The Study Coordinator is responsible for generating study protocols and amendments, animal care and use protocols and amendments, and study-related paperwork and procedures. The Study Coordinator manages protocol/amendment distribution and training notifications, as well as reviewing study-related materials before or following Study Director's review. Additionally, the Study Coordinator assists the Study Director group in ensuring the conduct of non-clinical studies in accordance with applicable regulatory guidelines and contemporary scientific practice. The Study Coordinator may also assist the Study Director group in the coordination of study-related activities including, but not limited to, proposal generation, routing documents for signatures, and interfacing with sponsors and vendors.
This is a non-exempt role and has no supervisory responsibility.
Role Responsibilities
- Generate draft protocols and amendments and ensure that the protocol, including any changes, is approved and followed.
- Generate animal care and use protocols and amendments.
- Route documents for approval.
- Distribute protocol and amendments to technical staff, QA, Study Director, Sponsor, and all principal investigators.
- Initiate training documentation for protocols and amendments.
- Compilation of data and data tabulation.
- Perform statistical analysis.
- Generate draft proposals in response to requests for proposals and client requests.
- Assist with data sharing with Sponsors.
- Interface with Sponsors, Vendors, Contributing Scientists, and Principal Investigators.
- Other duties as assigned.
Role Requirements
- Bachelor’s degree or equivalent in a related discipline.
- 1-5 years of experience in a GLP-compliant laboratory preferred.
- Distinctive qualifications (5-7 bullet points) that are necessary for an individual to be successful in the role.
- Proficiency with Microsoft Office core applications and the ability to learn and use additional applications.
- Good written and oral communication skills.
- Experience with scientific writing.
- Knowledge of GLPs (FDA, OECD, and MHLW) and other federal regulations relating to the care of laboratory animals.
- Excellent understanding of study design and protocols.
- Understanding of laboratory operations and data collection.
- Ability to work under specific time constraints.
Behavioral Expectations
- Time Management
- Dependability
- Self-Motivation
Special Requirements
- The person filling this position will spend approximately 90% in an office setting and 10% in the laboratory. There will be exposure to animal pathogens and chemicals. There will be handling of, and/or exposure to animal tissue and zoonotic organisms.
- Ability to don and wear personal protective gear, including N95 masks and respirators.
- Ability to spend part of the day standing and/or walking.
