Clinical Research Data & Regulatory Coordinator

OneOncology is positioning community oncologists to drive the future of medical care through a patient-centric, physician-driven, and technology-powered model to help improve the lives of everyone living with cancer and other diseases. Our team is bringing together leaders to the market place to help drive OneOncology’s mission and vision.

Why join us? This is an exciting time to join OneOncology. Our values-driven culture reflects our startup enthusiasm supported by industry leaders in oncology, urology, technology, and finance. We are looking for talented and highly-motivated individuals who demonstrate a natural desire to improve and build new processes that support the meaningful work of independent physicians and the patients they serve.

Job Description:

SCOPE: The Data and Regulatory Coordinator collaborates with the Clinical Research team and the Principal Investigator by  knowledge of current protocol requirements; maintains IRB documents, regulatory and protocol documentation for assigned clinical trials administered by the Center which may include multi-site trials; facilitates communication and correspondence between Clinical Research and sponsoring agencies; collects protocol specific information from physicians, nurses, patients, family members, local caregivers, and others utilizing protocol specific methods; ensures that all designated Clinical Research regulatory and data management activities for all clinical research sites  are executed in accordance with all applicable laws, regulations, policies and protocol requirements; performs additional duties as requested by supervisor and/or described in position description.

ESSENTIAL FUNCTIONS:                                                                            

1. Demonstrates knowledge and understanding of the evolution of clinical research.                                                                                                                  

2. Participates in clinical research studies by assuring that the regulatory and data for trials being managed according to rules and guidelines governing the conduct of clinical research trials.                   

3. Monitor/Auditor Preparation and Participation

4. IRB Preparation and Presentation

5. Protocol research document maintenance

6. Policies & procedures

7. Other duties and professional development

QUALIFICATIONS:

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.

• Basic science degree, or certification or licensure in a health care field

• Demonstrated success in management of regulatory submissions activities.

• Medical or scientific research experience preferred. 

• Professional Certifications preferred