Regulatory Specialist - Clinical Research

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To ensure clinical research trials are compliant with the federal and state laws, regulations, and rules governing healthcare which includes the rules and regulations concerning Conditions of Participation, Code of Federal Regulations, Good Clinical Practice and other regulations that govern clinical research studies.

Reports to Clinical Research Manager Education, Experience and Skills Requirements Bachelor's Degree in healthcare, business or related field. Must have healthcare knowledge or background in clinical research and/or medical terminology. Must have excellent interactive skills, as well as written and communication skills. Must be able to demonstrate appropriate conflict resolution in stressful situations. Must have excellent organizational skills with attention to detail. Must possess a working knowledge of computers and software applications such as Microsoft Word and Excel. Licensure/Certification Requirement Job Specific Competencies
Maintains accurate records and data base for large volume of clinical trials in preparation for sponsor, cooperative group or FDA audits and/or inspections.
Prepares, reviews and submits regulatory documents for clinical study submission to the Institutional Review Board, including initial and continuing review, modifications, event reporting, and informed consent. Maintains study regulatory files during entire clinical trial.
Maintains regulatory sections of the Research database. Maintains knowledge of the Institutional Review Board Policy, state law, and federal regulations as it pertains to clinical trials. Provides regulatory guidance to study coordinators. Assists sponsors and monitors in the review of study specific regulatory documents.
Performs orientation related to regulatory compliance for clinical coordinators and staff. Provides feedback to coordinators and managers on results of monitoring and audit activities.
Provides input on departmental plans, regular and special reports and programs in support of Clinical Research and Regulatory. Serves as a resource for coordinators and managers on accurate regulatory submissions. Recommends revisions to regulatory program and clinical research operations to improve effectiveness.
Core Competencies Customer Service
Interacts with customers in a warm and friendly way.
Takes immediate action to meet customer requests or needs.
Listens to understand what customers have to say. Safety
Recognizes safety hazards and takes corrective action; seeking assistance when needed.
Demonstrates knowledge of operational policies and procedures.
Performs work safely, without causing harm or risk to self, others or property. System Behavior
Makes a decision considering the impact of the decision on other areas.
Initiates collaboration with others outside of service area.
Demonstrates personal commitment to the principles, values, and ethics of the organization.
Models accountability for learning by sharing knowledge and learning from others. Interpersonal/Communication/Relationships
Builds effective working relationships.
Expresses appreciation to others for their work.
Treats others with respect. Leadership Competencies
Demonstrates both knowledge and application of Sanford policies, procedures, and guidelines.
Facilitates and supports change within the Sanford Health.
Demonstrates commitment to continuous learning for themselves and staff.
Demonstrates and applies continuous quality improvement knowledge and skills.
Professionalism/Integrity - Models high standards of principles, values and ethics through policy decisions, professional duties, and personal actions in the organization and the community. Information Management Competencies
Demonstrates skill in accessing, preparing and using information as relevant to position.
Verbalizes and demonstrates knowledge of procedures for maintaining security, confidentiality and integrity of employee, patient, family and other medical information.
Demonstrates ability to collect, analyze and present data as appropriate to position. Equipment Competencies
Demonstrates skill in use of equipment relevant to position; verbalizes knowledge of appropriate safety procedures.
Diagnoses equipment problems; fixes or seeks out someone to fix.
Consistently informs appropriate person of problems encountered with repairs or calibration of equipment. Blood Exposure
This position is classified as a Category III position under OSHA guidelines with no risk of exposure to bloodborne pathogens and other potentially infectious materials. Supervisory Dimension Physical Requirements: View Physical Requirements