The Clinical Research Assistant is responsible for coordinating, implementing and completing clinical research studies or clinical trials with the Orthogenetics Department at Nemours Children's Hospital Delaware. The job includes but is not limited to: developing protocols, recruiting patients, assisting in budget and documents preparation, in-servicing research teams, recruiting patients, obtaining patient consents, educating patients, conducting study procedures, collecting data, keeping records, performing analysis, and assisting in manuscript / abstract preparation.

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, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE.

Essential Functions:

1. Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting, and following up on Serious Adverse Events.
2. Assists in protocol preparation; assists in budget development; prepares documents as required by sponsoring agencies; develops source documents; develops consent and assent documents; prepares IRB memoranda.
3. Attends investigator meetings, as assigned; interacts with representatives of sponsoring agencies.
4. In-services staff for study purposes.
5. Recruits patients.
6. Develops strategies to assure study subject compliance with protocol requirements.
7. Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories.
8. Performs clinical data gathering and measurements.
9. Maintains study medication accountability records; maintains databases; assists in data analysis and manuscript / abstract preparation.
10. Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
11. Assists with stipend requests for patients.
12. Additional miscellaneous duties and responsibilities, as may be assigned from time to time by management.

Qualifications:

• At least 1 year clinical research experience
• Associate Degree is required (or in lieu of associate degree, two years of clinical research experience is required)
• Effectively uses Microsoft computer software
• Demonstrates ability to coordinate and establish priorities among diverse tasks
• Effectively communicates verbally and in writing