GENERAL SUMMARY
Under the supervision of the Director, Sports Medicine & Orthopedic Surgery Services and the 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 and quality studies and projects within the Sports Medicine and Orthopedic Surgery Service Line. Reports to the Director, Sports Medicine & Orthopedic Surgery Services.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assures and maintains professional standards for clinical practices in conducting clinical investigations and managing databases and registries.
Facilitates the design of essential documents (protocol, consent, case report forms, etc.), assists with the design and maintenance of project databases, as well as assists with training project teams on the guidelines for good clinical practice.
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 in appropriate files per institutional and regulatory requirements.
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.
Ensures compliance with research protocols performing reviews and audits, and interacts with principal investigators regularly.
In collaboration with management, monitors expenditures and adherence to study budgets where applicable.
Performs other duties as assigned.
LICENSES AND/OR CERTIFICATIONS
Current healthcare license (e.g. Registered Nurse, Athletic Trainer Certification, Physical Trainer, Occupational Trainer) highly preferred.
MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS
Bachelor's degree
Institutional Review Board (IRB) process familiarity required.
Knowledge of clinical research processes, procedures and regulations acquired through progressive experience in supporting or performing clinical research.
Minimum 1 year research experience required; 3+ years clinical research experience preferred.
Ability to effectively supervise work processes and team.
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.
Strong attention to detail, and competence to manage multiple priorities.
Ability to successfully work independently and in multidisciplinary group settings.
Must possess effective computer skills to include familiarity with Intermediate level experience with Microsoft Office (e.g. Excel) and other standard software.
WORKING CONDITIONS
Based on the projects, this position may be subject to 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 )
