Research Associate
Job description
Job Title: Research Associate
Location: Augusta University
Regular/Temporary: Regular
Full/Part Time: Full-Time
Job ID: 225353
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- Ability to maintain confidentiality
- Excellent interpersonal, written and verbal communication skills
- Detail-oriented with strong multi-tasking and organizational skills
- Proficient in Microsoft Office and other computer software/database
- Ability to follow protocols as designed; recognize potential adverse events and follow SOPs for reporting
- Willingness and ability to work flexible schedule to include early/late hours, nights/weekends, and up to two weeks on call per month
- 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.
- Must communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information.
- 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.
- 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 for 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.
- Responsible for data entry into sponsors 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.
- Must communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information.
- All Other duties as assigned