Research Associate- MCG- Clinical Trials Office

Job Summary

The Research Associate in this position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO). The CTO is an interdisciplinary research unit that provides support for physician-initiated, grant-funded, and industry sponsored clinical trials.

Responsibilities

• Recruitment of new study participants to include screening/randomization; management of study documents, regulatory, data entry and as requested assist with unfunded and/or investigator- initiated studies.
• Review studies to develop strategies for enrollment. Schedule pre-site visits, site initiation visits, study start up visits and monitoring visits.
• Ability to work as a team player to include responding to all correspondence in a timely manner and adjusting daily schedules to accommodate both the patient and investigator.
• Keep investigator informed of patient conditions, provide assistance to investigators in the management of adverse events to include changing the workflow to accommodate study amendments and principal investigator directions.
• Serve as patient advocates, scheduling follow-up appointments, coordinate care with other departments, perform all laboratory and other tests as required by the protocol. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies.
• Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs.
• As requested assist with audit preparation as well as respond to internal audits from the AU IRB Office.
• Must communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information.
• As requested attend meetings, computer trainings and workshops.
• Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month.
• Responsible for data entry into sponsor's EDC of choice and other data upload systems as well as maintenance of AU OnCore to include updating task lists, entering billing grid information into the financial console, and entering new patients as well as occurring completed visits.
• Perform all other job-related 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 of research and/or clinical experience.

Preferred Qualifications

Completion of Citi Program (Learner group 1 FDA regulated research). CCRC, CCRA, or CCRP certification is highly desirable; BLS certification is a plus.

Knowledge, Skills, & Abilities

Proficient in Microsoft Office and other computer software/databases.
SKILLS
Detail-oriented with strong organizational skills.
Excellent interpersonal, written, and verbal communication skills.
ABILITIES
Ability to maintain confidentiality.
Ability to work early/late hours, nights/weekends and up to two weeks on a call a month.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required).
Salary: $45,400-$46,200 annually.
Pay Band: B8
Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position.
Recruitment Period: Until Filled.
Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees.

Conditions of Employment

All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University.

Location

Augusta University
Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912
Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904

How To Apply

Search Job ID: 297607.
Select University Faculty & Staff > External Applicants if you are a candidate from outside the university.
Select University Faculty & Staff > Internal Applicants if you are a current university employee.
If you need further assistance, please contact us at 706-721-9365.
To apply, visit https://careers.hprod.onehcm.usg.edu/psp/careers/CAREERS/HRMS/c/HRS_HRAM_FL.HRS_CG_SEARCH_FL.GBL?Page=HRS_APP_JBPST_FL&Action=U&FOCUS=Applicant&SiteId=12000&JobOpeningId=297607&PostingSeq=1