Job Summary

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Attend post-award and/or pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results, including objectives, timelines, and reporting requirements.

Create/customize planning tools to facilitate prioritization of daily activities. Maintain department, study and inventory trackers in support of Project Scientist.

Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits. Serve as primary point of contact to the sponsor when study director/project scientist is not available.

With guidance, write initial protocol drafts. Upon study director/project scientist approval, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process.

Facilitate signature/approval process for protocol, amendments and other required forms.

Tabulate study data and schedule data review meetings.

Assist in the creation/generate special tables for sponsors as needed.

Assemble report (text and data tables) for senior scientific review, QA audits, and final report compilation.

Assist with management of QA audits and assure necessary corrections and follow-up take place.

Ensure that all study books are corrected appropriately, and that documentation is GLP compliant prior to submission to QA.

Assist in IACUC form preparation and perform IACUC literature searches.

Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOPs). Assist in drafting new or study specific SOPs.

Efficiently perform, review and document all study data, procedures, materials and results in compliance with applicable regulatory standards, SOPs, and methods/protocols.

Effectively complete administrative tasks such as filing and placing orders as needed.

Ensure documents align with requirements indicated in Client Information Database (CID).

Demonstrate effective communication skills through informal discussions with peers, supervisor, team and Sponsor/SDs.

Develop critical thinking, troubleshooting and time management skills aligned with needs of operational areas.

Perform all other related duties as assigned.

The pay range for this position is $24.00 - $25.00 per hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

Education: Bachelor's degree (B.A./B.S.) or equivalent in related discipline required.

Experience: Zero to two years related experience in biology, chemistry/pharmacy, or similar lab environment. GLP experience preferred.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure: None.

Other: This position requires analytical thinking skills and a good understanding of scientific processes. Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. Must be familiar with medical terminology and have a thorough understanding of technical aspects of research studies (e.g., observing dosing, treatments, surgical procedures, and necropsy evaluations). Knowledge of GLP regulations and understanding of routine study design and protocols.