Clinical Research Coordinator I (Regulatory) – Infectious Diseases Full-time

Regulatory Coordinator

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.

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. Resolves monitoring and auditing issues with regulatory files.
• 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 trial.
• May coordinate timely investigator assessment of safety reports.
• Proactively identifies regulatory issues and recommends process improvements in conjunction with a peer or supervisor.
• Keeps up to date on regulations and guidelines pertaining to clinical trial research.
• Serves as a regulatory information (federal, state, institutional) resource for faculty and research staff, and as the communication and strategic interface between faculty investigators and institutional review board(s).
• May maintain essential documents in audit ready order.
• Delegation of duty logs.
• Site visit logs.
• Signed protocol and investigational product documents.
• Study specific regulatory materials.
• Collects and maintains research staff CVs, Human Subjects and Good Clinical Practice Training records, professional licenses and various study related certifications.
• Collects and maintains CAP, CLIA, CVs lab normal from laboratories and other facilities used for research.
• Develops, prepares, submits, and maintains as needed, annual safety reports for clinical studies, including but not limited to DSMB reports, and inclusion and enrollment tables for grants.
• May develop, prepare, and submit, in collaboration with investigators, FDA Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications, and communicate with FDA as appropriate and requested by PIs.
• May develop, prepare, submit, and maintain annually or as needed, clinical study registration materials for Clinicaltrials.gov.
• Performs other duties incidental to the work described above.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications:

Education: Bachelor's degree or combination of education and/or experience may substitute for minimum education.

Certifications/Professional Licenses: No specific certification/professional license is required for this position.

Work Experience: No specific work experience is required for this position.

Skills: Not Applicable

Driver's License: A driver's license is not required for this position.

More About This Job:

• (Optional Based on Department) SOCRA/ACRP certification.

Preferred Qualifications:

Education: No additional education unless stated elsewhere in the job posting.

Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting.

Work Experience: No additional work experience unless stated elsewhere in the job posting.

Skills: Clinical Research, Clinical Study Protocols, Communication, Computer Systems, Interpersonal Communication, Organizing, Research Support

Grade: C09

Salary Range: $47,400.00 – $71,200.00 / 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. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.

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. Take advantage of our free Metro transit U-Pass for eligible employees. 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 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. Washington University is dedicated to building a 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.