Sr Clinical Research Professional - Emergency Medicine
Establish and maintain processes and monitors practices to ensure regulatory documentation involving clinical trials that comply with Institutional Review Board (IRB) and governmental policies and procedures and regulations. Support the clinical research team (physicians, nurses, coordinators, etc.) in research efforts by facilitating the protocol approval process and by maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. Be responsible for the administration and regulatory compliance of clinical research within the department.Primary DutiesRegulatory
- Prepare, submit, and assist Director with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Maintain regulatory documentation.
- Prepare and maintain FDA applications for INDs.
- Serve as resource person or act as consultant within area of regulatory expertise.
- Conduct internal audits.
- Make and assist in modifying protocols and study documents.
- Write reports, business correspondence, and procedure manuals.
- Demonstrate a comprehensive understanding of contract principles, federal regulations, laws and UC/UCPC policy and operating procedures.
- Work closely with UC and UC Health offices in negotiation of contracts, confidentiality agreements and amendments related to the conduct of research activities.
- Work with necessary parties to identify compliance, legal, IP and business/financial risk. Mitigate risk through working with physicians/faculty, divisions, legal and/or other departments.
- Prepare, develop, review and negotiate industry and sponsored research clinical trial budgets for consistency with UC/UCPC policies and operating procedures.
- Effectively negotiate budgets to obtain funding sufficient to successfully execute research as applicable.
- Assist in planning and implementing the clinical study’s goals and objectives; organize patient enrollment planning; conduct quality assurance activities; compile and analyze data.
- Coordinate nursing and patient care and/or patient follow-up functions of the clinical study including planning and developing related activities.
- Develop and implement procedures, maintain records, track progress, and conduct quality assurance on data collected.
- Act as a liaison with medical staff, University Departments, ancillary departments and/or satellite facilities.
- Perform quality checks on data entered by others.
- Assist with creation of case report forms.
- Database creation, testing, and basic maintenance.
- Act as liaison between study personnel and data entry specialists.
- Create data entry instructions and train data entry specialists.
- Related other duties, as assigned.
The University of Cincinnati, as a multi-national and culturally diverse university, is committed to providing an inclusive, equitable and diverse place of learning and employment. As part of a complete job application you will be asked to include a Contribution to Diversity and Inclusion statement.
As a UC employee, and an employee of an Ohio public institution, if hired you will not contribute to the federal Social Security system, other than contributions to Medicare. Instead, UC employees have the option to contribute to a state retirement plan (OPERS, STRS) or an alternative retirement plan (ARP).
The University of Cincinnati is an Affirmative Action / Equal Opportunity Employer / M / F / Veteran / Disabled.
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