• Conduct pre-visit home assessment phone calls with the study participant’s families and schedule the home health visits

• Travel to patients’ homes and conduct research assessments and questionnaires according to the study requirements

• Administer Investigational Product via IV infusion

• Monitor patient vitals

• Test urine before and after dosing

• Monitor and evaluate patient response to Investigational Products

• Fill out and submit home health visit documentation to our team.

REQUIRES valid RN License, prefer Compact RN License

• Develop and implement effective accounting policies and processes

• Ensure that financial records comply with federal, state, and local laws and regulations

• Maintain and organize digital and physical financial records

• Assess all business transactions and prepare accurate reports on your findings

• Conduct periodic audits to guarantee accuracy in financial records, expenses, and savings

• Organize and file all federal, state, and local income tax documents

• Contribute to annual budgeting process

• Regularly brief management on the company’s financial position and recommend solutions to improve results

• Remain up-to-date on industry changes and changes in regulation

• Respond to tax and accounting-related issues

• BA in Accounting or equivalent

• CPA certification

• 2-3 years experience as public accountant

• Complete initial and ongoing training related to clinical research protocols

• Conduct pre-visit home assessment phone calls with the study participant’s families and schedule the home health visits

• Travel to patients’ homes and conduct research assessments and questionnaires according to the study requirements (travel may be up to 70%)

• Administer Investigational Product via IV infusion, and monitor/evaluate patient response when needed

• Monitor patient vitals

• Conduct safety labs, including aliquoting and centrifuging, packaging and shipping sample

• Fill out and submit home health visit documentation to our team

• Conduct home health nurse training on site at RDR sites or at subject’s home

• Supervise home health nurses conduct study visits virtually or at subject’s home

• Review visit reports and maintain quality metrics

• Create, update and maintain standard operating procedures (SOPs) for home health visit processes

• Communicate with sites and sponsors as needed to resolve queries related to home visits

• Undergraduate or Master’s degree in Nursing

• Active RN license in the State of Georgia and compact license

• Previous home health or in-patient experience with pediatric patients

• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

• Collects documents needed to initiate the study and submit to the sponsor (e.g., Form FDA 1572, CVs, etc.)

• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

• Collect or coordinate collection of clinical procedures such as vital signs, ECGs, blood draws, IP infusions.

• Responsible for timely data entry and query resolutions

• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

• Other duties as assigned

• Requires at least 2 years previous experience as a CRC in a clinical research trial setting