The Clinical Research Assistant will be responsible for assisting in the coordination of pediatric clinical research studies for the OrthoGenetics Department Research Team.

The job includes but is not limited to: screening patients for study eligibility, scheduling research visits/follow up, tracking/auditing consent forms and study related documents, preparation for both internal and external audits, collecting data and submitting to appropriate organizations, processing/packaging of lab specimens, maintaining inventory of research supplies, creating electronic research charts, scheduling site monitor visits and meeting rooms as needed and assisting in the implementation of new laboratory protocols and processes.

This is a fast- paced working environment involving time sensitive specimens and hard deadlines for data submissions. A high level of organization with attention to detail and the ability to manage multiple responsibilities is required.

This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset.

The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training and CITI training (including Good Clinical Practice (GCP).

Required skills include ability to work with children, experience with computer data entry and statistical analyses, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE.

Essential Functions:

1. Prepare and maintain regulatory aspects of a study protocol from start to finish including preparation of regulatory start- up packets for research grants and pharmaceutical companies
2. Screens patients for study eligibility by attending meetings and utilizing the electronic health record EPIC.
3. Recruit patients for studies to include: preparation and advertising requests and interviewing patients to determine appropriateness for research study
4. Preparing patient notebooks/binders, recording and maintaining accurate data in research notebooks/binders, developing data collection tools, collecting data, monitoring and ordering supplies (registries and retrospective studies)
5. Interact with Principal Investigators, research study team, and study monitors
6. Compliance with minimal research training (human subjects protection, good clinical practice, and Nemours University)
7. Assist with stipend request for patients
8. Assist with specimen preparation and shipping
9. Develops strategies to ensure study subject compliance with protocol requirements.
10. Additional miscellaneous duties and responsibilities, as may be assigned from time to time by employee's supervisor.

Qualifications:

• At least 1 year clinical research experience
• Associate's degree in medical or science related field required
• Effectively uses Microsoft computer software
• Demonstrates ability to coordinate and establish priorities among diverse tasks
• Effectively communicates verbally and in writing