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Mayo Clinic · 1 day ago

Regulatory Affairs Coordinator – Cancer Center Compliance (Remote)

United States

Full-time

Remote

Mid, Senior Level

$74K/yr - $112K/yr

5+ years exp

Mayo Clinic is a top-ranked healthcare provider dedicated to putting the needs of patients first. They are seeking a Regulatory Affairs Coordinator to oversee compliance activities related to human subjects and investigational use of agents, ensuring adherence to regulatory standards and facilitating the development of policies and procedures.

BiotechnologyHealth CareHospitalMedicalWellness

No H1B

U.S. Citizen Only

Responsibilities

Responsible for planning and implementation of compliance activities associated with the protection of human subjects and investigational use of agents (drugs, biologics, device, etc)

Monitors the internal and external regulatory environment to promote centralized, coordinated, and proactive identification, development, and implementation of new or revised policies, procedures, etc. applicable to MCCC research programs

Researches relevant regulatory issues and evaluates the adequacy and effectiveness of compliance processes and controls related to Mayo Clinic Cancer Center (MCCC) research programs

Proposes compliance-enhancing recommendations to MCCC leadership and facilitates the development and implementation of new or revised MCCC policies and procedures pertaining to human research protections and the investigational use of agents

Through these activities, facilitates, the compliance of MCCC research programs with Mayo Foundation and National Cancer Institute (NCI) policies, and U.S. and foreign government regulations, including those of the U.S. Food and Drug Administration, Health Canada, and other equivalent agencies

Participates in other compliance-related administrative activities including development and delivery of educational programs, and assistance, as necessary, during select external audits and site visits (i.e., FDA, and NCI or other sponsors)

Serves as a resource concerning policies, procedures, and regulations applicable to MCCC research programs

Represents the MCCC research programs from a regulatory perspective in national forums/venues

Presentations at meetings or other conferences, seminars, and classes, and occasional travel may be required

Manages the submission and ongoing maintenance of U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications, Health Canada Clinical Trials Applications (CTAs), and other equivalent activities as may be applicable to the research programs of the MCCC

Supports the MCCC Protocol Review and Monitoring System (PRMS), and the MCCC Clinical Research Office, and promotes efficiency and adaptability through the coordinated development and maintenance of policies, working instructions, standard operating procedures, protocol templates, etc., related to the protection of human subjects and investigational use of agents (drugs, biologics, etc)

May have direct supervisory responsibilities

Qualification

ComplianceQuality ManagementFDA RegulationsMedical TerminologyProject ManagementAnalytical SkillsComputer LiteracyCert Clinical Res ProfessionalCert Clinical Research AssocCertified Clinical Research CoRegulatory Affairs CertificateCertified IRB ProfessionalCommunication SkillsLeadership SkillsDetail Oriented

Required

A bachelor's degree (BA, BS) and a minimum of 5 years' experience in compliance, quality management, audit, or other relevant healthcare experience is required

Knowledge and experience in the interpretation and application of laws and regulations relating to human subjects' research protections and investigational use of agents (drugs, biologics, etc.) are required

Exceptional human relations skills and excellent communication skills (written, verbal, and listening) are required

Organizational project management skills are essential

Should have an inquiring, analytical and persistent disposition to enable the asking of follow-up questions that might not occur to others and look deeply into each area of concern

Collaborates with management in identifying improvement opportunities and developing corresponding solutions

Must be flexible and capable of adapting to and facilitating change

Must be very detail oriented

Must have the ability to work independently and productively with a minimum of direction and to routinely exercise initiative and sound judgment

Must possess effective leadership and management qualities, including the ability to motivate and to influence others

Compliance issues may create difficult situations for the involved individuals. Therefore, fairness in approach is essential

Objective and dispassionate interest in issues must be maintained, while maintaining mutual respect for individuals

Computer literacy and medical terminology are essential

Must be efficient in the use of personal computers for word processing, spreadsheets, data analysis, creation of graphs and charts, presentations, electronic communications, and research

Must have demonstrated the capacity to comprehend complex structures and connections

The ability to exercise good judgment in ambiguous situations while under pressure; strong coping skills are required

Must be flexible in adapting to a variety of responsibilities, work assignments, and priorities

Preferred

A strong understanding of FDA regulations and proficiency in medical terminology is preferred

The following certifications are preferred: Cert Clinical Res Professional (CCRP), Cert Clinical Research Assoc (CCRA), Certified Clinical Research Co (CCRC) and Regulatory Affairs Certificate (RAC) and Certified IRB Professional (CIP)