To support the regulatory team in maintaining superior performance in assuring all regulatory tasks and documents are accurate, complete, and properly processed to external and internal contacts; Promotes quality and efficiency in the regulatory process of Lindner Research-Oncology achieving accuracy and completing tasks quickly to facilitate early start-up.
Coordinates and performs efforts associated with the preparation of documents or submissions to corporate sponsors, IRB, FDA, or other regulatory agents in a timely and accurate manner.
Assures all regulatory packets are complete and any required follow-up or adjustments are performed in a timely manner, allowing department to maintain its position of first initiated or early entry site; independently communicates with the sponsors to define tasks and assure efficiency in completion, representing Lindner Research-Oncology in a professional manner.
Maintains current knowledge base of existing and emerging regulations, standards, or guidelines to assure actions are in compliance with standards upon which the department’s regulatory product will be judged. Participates in new employee regulatory awareness training.
Makes recommendations to Executive Assistant to the Director that may enhance the department’s regulatory process to become more efficient and responsive to the needs of corporate sponsors
Meets with CRA’s/auditors of sponsor to address any regulatory questions or issues; follows up on all required tasks at the time of discussion or prior to the next review; participates in internal and external audits
Compiles and maintains regulatory files; creates and maintains an accurate and complete log on all trials, indicating their PI, sponsor, functional status, study nurse and associated team members, IRB numbers, and statuses.
Maintains Lindner Research-Oncology website, assuring all trials are listed with current information to allow viewer assessment of trial eligibility; triages all consumer questions to the appropriate individual for timely feedback
Completes reports of adverse events in an accurate manner; processes all safety information alerting appropriate staff and physician staff as required.
Performs other duties as assigned.
KNOWLEDGE AND SKILLS:
Please describe any specialized knowledge or skills, which are REQUIRED to perform the position duties. Do not personalize the job description, credentials, or knowledge and skills based on the current associate. List any special education required for this position.
EDUCATION: High School education or its equivalent, Associate degree, majoring in Business is preferred.
YEARS OF EXPERIENCE: 3-5 years Medical Office experience required. Research and Regulatory experience preferred.
REQUIRED SKILLS AND KNOWLEDGE: Photocopier, fax equipment, computer, ability to make independent decisions, and strong organizational skills. Telephone etiquette and excellent communication skills required.
LICENSES & CERTIFICATIONS:
The Christ Hospital Health Network is a regional system of care that extends The Christ Hospital's 130 years of exceptional care and leadership to more than 100 locations in the Greater Cincinnati area.
Our team delivers integrated, individualized healthcare and wellness services through a comprehensive physician network, advanced specialty services and the region's Most Preferred Hospital (National Research Corporation).
Our mission is to improve the health of our community and create patient value by providing exceptional outcomes, affordable care and the finest experiences. To learn more about our locations and award-winning services, visit TheChristHospital.com.
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