University of Cincinnati
Clinical Research Professional, Department of Emergency Medicine
University of Cincinnati, Cincinnati, Ohio, United States, 45208
Clinical Research Professional, Department of Emergency Medicine
Current UC employees must apply internally via
SuccessFactors
> http://bit.ly/UCEMPLFounded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to 53,235 students, more than 11,000 faculty and staff and 350,000+ living alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls "the most ambitious campus design program in the country."With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, three straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC's momentum has never been stronger. UC's annual budget stands at $1.85 billion, and its endowment totals nearly $1.8 billion.Job OverviewAs one of the oldest medical schools in the country, the UC College of Medicine has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients.
The UC Department of Emergency Medicine at the University of Cincinnati has been an independent academic unit within the College of Medicine since 1984. It is responsible for the medical direction of the University of Cincinnati Medical Center, Center for Emergency Care (CEC) and the Emergency Medicine Residency Training Program.
The Department of Emergency Medicine is seeking a Clinical Research Professional who will serve as the research division's regulatory coordinator in charge of regulatory submissions to the IRB and FDA, sponsor interface, document management and research compliance. This team member will work with the clinical research professionals team that coordinates research studies in an acute care setting.Essential FunctionsParticipant Management: Recruit or assist in the recruitment of study participants based on study criteria, Consent participants into research studies, schedule and conduct participant study visits, coordinate tests and procedures with medical staff.Manage investigational products including ordering, storage and return or destruction of study drugs, devices or lab supplies.Accurately record clinical and study data from participant visits, entering into CRF or electronic data capture in a timely manner and ensure completeness of study records.Work closely with principal investigator and other healthcare providers to ensure smooth study operations.Stay current with relevant medical knowledge, clinical guidelines and therapeutic advancements related to the study's area of focus.Educate research and clinical staff on protocol details, ensuring consistent understanding and application across the study team.Collaborate with investigators, clinical staff and institutional teams to design and implement study specific order sets with the EMR.Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members.Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.Ensure research is conducted according to the study protocol, compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.Prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).Prepare and maintain FDA applications for investigational New Drugs (INDs). Maintain regulatory documentation.Assist in modifying protocols, reports and procedure manuals.Writing of consents and creation of study documents.Conduct adverse event reporting to both study authorities, institutional authorities and regulatory authorities. Manage office documents including training certificates, CVs, and licenses.Act as liaison between participants, investigators, study personnel, study sponsors and regulatory bodies.Prepare for site monitoring visits, audits and inspections by sponsors or regulatory bodies.Perform related duties based on departmental need. This job description can be changed at any time.
Required Education
Bachelor's Degree in Biology, Health Sciences, or a related field.Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
Additional Qualifications Considered
Master's degree.Experience working in an academic research setting.Experience with Redcap or eRegulatory.Clinical Research Professional Certification.
Physical Requirements/Work Environment
Sitting - Continuously
Compensation and BenefitsUC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.Competitive salary range dependent on the candidate's experience.Comprehensive insurance plans including medical, dental, vision, and prescription coverage.Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.Tuition remission is available for employees and their eligible dependents.Enjoy discounts for on and off-campus activities and services.
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).To learn more about why UC is a great place to work, please visit our careers page at https://www.uc.edu/careers.html.For questions about the UC recruiting process or to request accommodations with the application, please contact Human Resources at jobs@uc.edu.The University of Cincinnati is an Equal Opportunity Employer.REQ:97549SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN SF:IHEClinical Research Professional, Department of Emergency Medicine
Date:
Oct 30, 2024
Location:
Cincinnati, OH, US
Facility:
Main Campus
Nearest Major Market:
Cincinnati
Job Segment:Emergency Medicine, Clinical Research, Medical Research, Compliance, Healthcare, Research, Legal
Current UC employees must apply internally via
SuccessFactors
> http://bit.ly/UCEMPLFounded in 1819, the University of Cincinnati ranks among the nation's best urban public research universities. Home to 53,235 students, more than 11,000 faculty and staff and 350,000+ living alumni, UC combines a Top 35 public research university with a physical setting The New York Times calls "the most ambitious campus design program in the country."With the launch of Next Lives Here, the Cincinnati Innovation District, a $100 million JobsOhio investment, three straight years of record enrollment, worldwide leadership in cooperative education, a dynamic academic health center and entry into the Big 12 Conference, UC's momentum has never been stronger. UC's annual budget stands at $1.85 billion, and its endowment totals nearly $1.8 billion.Job OverviewAs one of the oldest medical schools in the country, the UC College of Medicine has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients.
The UC Department of Emergency Medicine at the University of Cincinnati has been an independent academic unit within the College of Medicine since 1984. It is responsible for the medical direction of the University of Cincinnati Medical Center, Center for Emergency Care (CEC) and the Emergency Medicine Residency Training Program.
The Department of Emergency Medicine is seeking a Clinical Research Professional who will serve as the research division's regulatory coordinator in charge of regulatory submissions to the IRB and FDA, sponsor interface, document management and research compliance. This team member will work with the clinical research professionals team that coordinates research studies in an acute care setting.Essential FunctionsParticipant Management: Recruit or assist in the recruitment of study participants based on study criteria, Consent participants into research studies, schedule and conduct participant study visits, coordinate tests and procedures with medical staff.Manage investigational products including ordering, storage and return or destruction of study drugs, devices or lab supplies.Accurately record clinical and study data from participant visits, entering into CRF or electronic data capture in a timely manner and ensure completeness of study records.Work closely with principal investigator and other healthcare providers to ensure smooth study operations.Stay current with relevant medical knowledge, clinical guidelines and therapeutic advancements related to the study's area of focus.Educate research and clinical staff on protocol details, ensuring consistent understanding and application across the study team.Collaborate with investigators, clinical staff and institutional teams to design and implement study specific order sets with the EMR.Act as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.Serve as a peer-mentor within the department, supporting management and in various responsibilities as appropriate including the development of less experienced team members.Contribute to the development of new processes, procedures, tools and training to enhance clinical research activities, compliance, and efficiency.Ensure research is conducted according to the study protocol, compliance with contract principles, federal regulations, laws and University of Cincinnati/University of Cincinnati Physicians Company (UCPC) policy and operating procedures.Prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).Prepare and maintain FDA applications for investigational New Drugs (INDs). Maintain regulatory documentation.Assist in modifying protocols, reports and procedure manuals.Writing of consents and creation of study documents.Conduct adverse event reporting to both study authorities, institutional authorities and regulatory authorities. Manage office documents including training certificates, CVs, and licenses.Act as liaison between participants, investigators, study personnel, study sponsors and regulatory bodies.Prepare for site monitoring visits, audits and inspections by sponsors or regulatory bodies.Perform related duties based on departmental need. This job description can be changed at any time.
Required Education
Bachelor's Degree in Biology, Health Sciences, or a related field.Five (5) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.
Additional Qualifications Considered
Master's degree.Experience working in an academic research setting.Experience with Redcap or eRegulatory.Clinical Research Professional Certification.
Physical Requirements/Work Environment
Sitting - Continuously
Compensation and BenefitsUC offers a wide array of complementary and affordable benefit options, to meet the financial, educational, health, and wellness needs of you and your family. Eligibility varies by position and FTE.Competitive salary range dependent on the candidate's experience.Comprehensive insurance plans including medical, dental, vision, and prescription coverage.Flexible spending accounts and an award-winning employee wellness program, plus an employee assistance program.Financial security via our life and long-term disability insurance, accident and illness insurance, and retirement savings plans.Generous paid time off work options including vacation, sick leave, annual holidays, and winter season days in addition to paid parental leave.Tuition remission is available for employees and their eligible dependents.Enjoy discounts for on and off-campus activities and services.
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).To learn more about why UC is a great place to work, please visit our careers page at https://www.uc.edu/careers.html.For questions about the UC recruiting process or to request accommodations with the application, please contact Human Resources at jobs@uc.edu.The University of Cincinnati is an Equal Opportunity Employer.REQ:97549SF:OMJ SF:RM SF:HEJ, SF:INS SF:HERC SF:DIV SF:LJN SF:IHEClinical Research Professional, Department of Emergency Medicine
Date:
Oct 30, 2024
Location:
Cincinnati, OH, US
Facility:
Main Campus
Nearest Major Market:
Cincinnati
Job Segment:Emergency Medicine, Clinical Research, Medical Research, Compliance, Healthcare, Research, Legal