Research Associate

About the role

The position involves performing advanced administrative and technical work in support of clinical research trials. Key responsibilities include preparing new clinical trial research protocols for IRB submission, coordinating with campus departments, managing protocol amendments, financial disclosures, protocol deviations, and adverse events. Regulatory activities such as uploading documents into OnCore and IRBNet, supporting clinical investigators, and conducting quality control inspections are also part of the role.

Responsibilities

• Prepares new clinical trial research protocols for IRB submission, ensuring compliance with FDA, DHHS, ICH, state of Georgia, AU, and Wellstar MCG Health regulations.
• Captures regulatory activities associated with ongoing clinical research protocols, including protocol amendments, financial disclosures, protocol deviations, and adverse events.
• Uploads regulatory documents into OnCore and IRBNet, and acts as a liaison between clinical trial sponsors, clinical investigators, and the IRB.
• Maintains a training schedule for cancer center research faculty and staff, assists with finding and distributing continuing education opportunities, and performs quality control regulatory inspections.
• Performs other duties as assigned.

Required Qualifications

• A 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, with experience in research, basic science, or clinical laboratory, particularly clinical trial research.
• Alternatively, a Bachelor's degree from an accredited college or university in the same fields, combined with 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).
• Ability to coordinate multiple projects simultaneously, meet deadlines despite interruptions, maintain confidentiality, keep accurate records, and make independent decisions.
• Knowledge of FDA/GCP regulations and adequate computer skills (Word, Excel, Adobe Acrobat) to navigate online tools like IRB.net and OnCore.

Shift/Salary/Benefits

Shift: Days/M-F (work outside of normal business hours may be required)

Pay Band: B8

Salary Range: $45,400/annually - $56,700/annually

Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position.

Recruitment Period

Recruitment Period: 6295/26 - Until Filled

Conditions of Employment

• All selected candidates must successfully pass a Background Check review prior to starting with Augusta University.
• Final candidates for Faculty positions will be required to provide proof of completed academic degree(s) and post-secondary coursework in the form of original transcripts. Foreign-trained candidates will also be required to provide an educational/credential evaluation.
• All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive information by exercising sound judgement and adhering to cybersecurity and privacy policies during their employment and beyond.

Equal Employment Opportunity

Augusta University is proud to be an equal opportunity employer welcoming applicants from underrepresented groups, including individuals with disabilities and veterans.