Regulatory Assistant - MOB Linder Research HV - Full Time - Days
The Christ Hospital Health Network, Cincinnati, OH, United States
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.
Responsibilities
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 the 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 the 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 sponsors 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.
Qualifications
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 : (None specified).
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Responsibilities
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 the 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 the 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 sponsors 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.
Qualifications
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 : (None specified).
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