Clinical Research Data & Regulatory Coordinator Mary Bird Perkins Cancer Center - 3.9 Baton Rouge, LA Job Details Full-time 18 hours ago Qualifications Mid-level Collaborative research Bachelor's degree Data management Research compliance clinical trial records management Organizational skills Presentation preparation Communication with regulatory authorities for clinical trials Patient interaction IRB compliance Ethical review application preparation Full Job Description Mary Bird Perkins Cancer Center is Louisiana's leading cancer care organization, caring for more patients each year than any other facility in the region. And with strategic hospital and physician partnerships, we are delivering on our mission to improve survivorship and lessen the burden of cancer. Mary Bird Perkins and its partners work together to provide state-of-the-art treatments and unparalleled collaborative, comprehensive cancer services. This culture of innovation helps attract the best cancer minds in the country, from expert physicians and highly specialized scientists to forward-thinking leaders in supportive care and other disciplines. Together, with our hospital and physician partners, we are one-hundred percent focused on cancer care. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we 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