Description:

• Will be supporting pediatric hematology oncology and gastrointestinal clinical research trials
• Trials will be a combination of consortium multi-site trials, NIH trials as well as industry
• Enrolling patients, collecting data and entering it into the EDX system
• Answering data queries, cleaning data, assisting with opening and closing with the IRB
• Also will have regulatory responsibilities such as collecting research certifications, financial disclosures.
• Maintenance of regulatory documents and binders, data management, IRB submissions and communication of such to the research team, and the development of data capture and monitoring plans
• May be responsible for reporting of (SAE's) Serious Adverse Events and/or safety log as defined per protocol as they occur and completion of Food and Drug Administration (FDA) and sponsor forms in accordance with GCP guidelines
• Communicates with sponsors, monitors, and research personnel to ensure all aspects of study compliance
• Serves as a liaison between investigators, research personnel, outside study personnel and central research administration offices to assist in protocol interpretation, enrollment and safety questions
• Collaborates with primary investigator, sponsor and research staff to plan, conduct and evaluate project protocols, including research subject recruitment

Additional Skills & Qualifications:

• Must have a BA
• MUST be okay with working on pediatric trials and supporting ill children

Experience Level:

Entry Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.