Apply on Employer Site

Children's Hospital of The King's Daughters · 10 hours ago

Research Compliance Specialist

Norfolk, VA

Full-time

Onsite

Mid Level

3+ years exp

Children's Hospital of The King's Daughters is seeking a Research Compliance Specialist to support research compliance and policy needs. This role involves developing, implementing, and monitoring compliance policies and procedures, providing guidance and training to researchers, and ensuring external audit readiness.

ChildrenHealth CareHospital

Responsibilities

Provides research compliance program administration by interpreting and applying research compliance rules and regulations for the university and its community, research sponsors, and regulatory entities

Promotes best practices, quality improvement, and institutional compliance with sponsoring agency obligations

Organizes data, extract information, and help prepare reports for the Director

Maintains and enhances existing procedures and training that support the Department’s compliance programs and guidelines

Conducts regular audits and inspections to identify and resolve any instances of non-compliance and mitigate risks

Leads the internal auditing team to ensure external audit readiness

Serves as the primary liaison for any external audit from an external sponsor or other external regulatory entity

Collaborates with Legal, IRB, and the Clinical Operations Team to ensure audit coordination and institutional alignment

Develops and implements comprehensive compliance policies and procedures that ensure the organization’s research activities adhere to all applicable laws and regulations

Provides guidance and educational opportunities to research faculty, staff, and students concerning research regulations, compliance, and procedures

Serves as a trusted liaison between organizations and regulatory agencies

Performs all other duties as assigned

Qualification

Regulatory affairsCompliance policy developmentAudit readinessOrganizational skillsCross-cultural communication

Required

Bachelor's degree in relevant fields such as biology, public health, or regulatory affairs

Minimum 3-5 years of experience in regulatory affairs role

Familiarity with regulatory agencies and bodies

Strong organizational, leadership, and cross-cultural communication skills

Preferred

Experience in academic research is highly preferred

Company

Children's Hospital of The King's Daughters

Glassdoor3.4

Children’s Hospital of The King’s Daughter’s (CHKD) Health System operates Virginia’s only freestanding, full-service children’s hospital and its pediatric practices, multi-service health centers, and urgent cares throughout southeastern Virginia and northeastern North Carolina.

Founded in 1961

Norfolk, Virginia, USA

1001-5000 employees