Research Associate

Job Summary

Performs advanced administrative and technical work in support of clinical research trials. Manages several large, multi-center, Investigator-initiated, federal, and industry sponsored clinical trials.

Responsibilities

The responsibilities include, but are not limited to:

• Prepares new clinical trial research protocols for IRB submission, in compliance with all applicable regulations and policies of FDA, DHHS, ICH, state of Georgia, AU, and AUMC. Coordinates activities with respective campus departments to ensure successful study execution.
• Performs regulatory activities associated with the ongoing management of current clinical research protocols, including, but not limited to, protocol amendments, financial disclosure, protocol deviations, protocol departures, adverse events.
• Responsible for uploading regulatory documents into OnCore and IRBNet. Provides regulatory support to cancer center clinical investigators and clinical staff. Acts as a liaison between clinical trial sponsors (or contract research organizations), clinical investigators, and the IRB, and coordinates efforts towards the startup and ongoing conduction of a clinical trial until close out of study.
• Creates and maintains training schedule for cancer Center research faculty and staff related to research compliance best practices. Assists with finding and distributing continuing education requirement opportunities. Performs quality control regulatory inspections of cancer center clinical trials to ensure regulatory compliance.
• Other duties as assigned.

Required Qualifications

Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research.

OR

Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience.

Preferred Qualifications

Clinical Research Professional/Associate/etc. certificates.

Knowledge, Skills, & Abilities

Excellent customer service, interpersonal, multi-tasking, organizational and verbal/written communication skills.

Proficiency with Microsoft Office (Word, Excel, Access, and PowerPoint) and other computer software/databases.

Ability to coordinate multiple projects simultaneously, meet deadlines despite often interruptions, maintain confidentiality, keep accurate records and make independent decisions.