Clinical Research Coordinator I (Regulatory) - Oncology
Scheduled Hours
40
Position Summary
Clinical research is a heavily regulated field. It is regulated at the federal level by the Department of Health and Human Services, Office of Human Research Protections, the Food and Drug Administration, the Office of Civil Rights, to name a few. There are state and local rules, regulations and statutes that may impact the conduct of clinical research. In addition, institutional policies from the University, School of Medicine and the Division also come into play. The regulatory coordinator's responsibilities are to keep the studies' regulatory statuses up-to-date, obtain necessary information to submit to the IRB and other regulatory bodies to maintain compliance with various rules, laws, regulations and policies at each stage of a clinical study.
Job Description
Primary Duties & Responsibilities
Preferred
Qualifications:
Required Qualifications
REQUIRED LICENSURE/CERTIFICATION/REGISTRATION
Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Basic Life Support certification must be obtained within one month of hire date.
Grade
C09
Salary Range
$46,400.00 - $69,700.00 / Annually
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Benefits Statement
Personal
Wellness
Family
For policies, detailed benefits, and eligibility, please visit:
https:
//hr.wustl.edu/benefits/
EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Diversity Statement
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.Estimated Salary: $20 to $28 per hour based on qualifications.
40
Position Summary
Clinical research is a heavily regulated field. It is regulated at the federal level by the Department of Health and Human Services, Office of Human Research Protections, the Food and Drug Administration, the Office of Civil Rights, to name a few. There are state and local rules, regulations and statutes that may impact the conduct of clinical research. In addition, institutional policies from the University, School of Medicine and the Division also come into play. The regulatory coordinator's responsibilities are to keep the studies' regulatory statuses up-to-date, obtain necessary information to submit to the IRB and other regulatory bodies to maintain compliance with various rules, laws, regulations and policies at each stage of a clinical study.
Job Description
Primary Duties & Responsibilities
- Writes and prepares Institutional Review Board (IRB) regulatory submissions, including, but not limited to, consent forms, new project applications, amendments, continuing review application, exceptions, and promptly reportable information.
- Coordinates submissions to ancillary committees such a Protocol Review and Monitoring Committee, Radioactive Drug Research Committee, and Institutional Biological and Chemical (IBC) Safety Committee
- Maintains accurate records related to the regulatory aspects of research to ensure that regulatory files are audit-ready.
- Maintains compliance with regulatory requirements and institutional policies.
- Serves as the primary regulatory contact for studies and collaborates with study investigators, study coordinators, sponsors, and Clinical Research Organization (CRO) to coordinate study start-up activities and ongoing regulatory activities throughout the life of the study.
- May coordinate timely investigator assessment of safety reports.
- Proactively identifies regulatory issues and recommends process improvements.
- Performs other duties incidental to the work described herein.
Preferred
Qualifications:
- Effective verbal, written, and interpersonal communication skills
- Effective organization skills
- Working knowledge of computer programs and systems
- Ability to work independently outside a traditional office setting
Required Qualifications
- Bachelor's degree.
- A combination of college education and relevant experience equaling four years may substitute for this requirement.
REQUIRED LICENSURE/CERTIFICATION/REGISTRATION
Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Basic Life Support certification must be obtained within one month of hire date.
Grade
C09
Salary Range
$46,400.00 - $69,700.00 / Annually
The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.
Accommodation
If you are unable to use our online application system and would like an accommodation, please email CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.
Pre-Employment Screening
All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.
Benefits Statement
Personal
- Up to 22 days of vacation, 10 recognized holidays, and sick time.
- Competitive health insurance packages with priority appointments and lower copays/coinsurance.
- Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.
- WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%.
Wellness
- Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more!
Family
- We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered.
- WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us.
For policies, detailed benefits, and eligibility, please visit:
https:
//hr.wustl.edu/benefits/
EEO/AA Statement
Washington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.
Diversity Statement
Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.Estimated Salary: $20 to $28 per hour based on qualifications.
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