GENERAL SUMMARY
Under the supervision of the department manager and responsible research investigator(s), this position is responsible for the administration, coordination, database management and reporting requirements for the designated department(s) approved clinical research. Reports to department leadership.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assures and maintains professional standards for clinical practices in conducting clinical investigations.
Possesses and maintains an in-depth knowledge of federal regulations and guidance documents required for clinical trials and human subject protection, assuring compliance with protocol and regulatory requirements, and by collecting, recording and maintaining data and source documents.
Coordinates and directs work flow and functions of personnel to facilitate safe and efficient work flow and practices.
Effectively hires, supervises, orients, trains and evaluates designated research personnel.
Performs other duties as assigned.
LICENSES AND/OR CERTIFICATIONS
Current healthcare license (e.g. RN, ATC, PT, OT) required.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS
Bachelor's degree required.
Knowledge of clinical research processes, procedures and regulations acquired through progressive experience in supporting or performing clinical research.
3-5 years clinical research experience and doctoral degree preferred.
IRB familiarity preferred.
Ability to effectively supervise work processes and personnel.
Superior communication and interpersonal skills necessary to propose, promote, coordinate, recommend and administer changes in practice and processes to achieve and maintain the efficacy of research workflow.
Must possess effective computer skills to include familiarity with Microsoft Excel, Access, and other standard software.
WORKING CONDITIONS
Frequent exposure to communicable diseases, toxic substances, hazardous materials, radiation, radio nucleotides, medicinal preparations, body fluids and other conditions common to the healthcare environment.
PHYSICAL REQUIREMENTS
Click here to view physical requirements. (https://www.chkd.org/uploadedFiles/Documents/Employees/Category%20B1%20Jobs.pdf )
