Regulatory Specialist II, Clinical Trials

DescriptionJob Summary: In addition to the responsibilities listed below, this position is also responsible for beginning to ensure that research team members are working in compliance with state, federal, and institutional regulatory requirements (e.g., Food and Drug Administration (FDA) regulations, National Institute of Health guidelines, human research protection); beginning to develop and train on-site procedures pertinent to regulatory compliance in consultation with site staff; preparing components of Institutional Review Board (IRB) and/or FDA documents with some guidance; supporting the preparation and maintenance of study-related regulatory documents (e.g., protocol and consent forms, brochures, events documentation, compassionate use application); supporting regulatory quality assurance activities for the department; assisting in the preparation for internal and external inspections and audits; maintaining and/or supporting the development of policies and procedures for new guidance/regulatory standards; and completing standard investigational product applications for approval.Essential Responsibilities:Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback. Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work. Assesses and responds to the needs of others to support a business outcome.Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship. Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports the completion of priorities, deadlines, and expectations. Identifies and speaks up for ways to address improvement opportunities.Assists in budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard projects.Conducts clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of clinical trials, studies, and interventions at the site-level; contributing to the development of standard clinical research protocols and other processes of clinical trials with limited guidance; supporting the preparation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens), with guidance.Supports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.Learns to maintain internal and external effective working relationships by: leveraging a working knowledge of how to support important research stakeholders and projects within their unit; communicating, under minimal guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance.Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) with general directions and limited guidance; assisting with the development of standard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a working knowledge of how to monitor and audit Clinical Trials as well as documenting findings.QualificationsMinimum Qualifications:Bachelors degree in Science, Public Health, Health Care Administration, or a directly related field OR Minimum three (3) years of experience in clinical research or a directly related field.Job Field: Clinical TrialsJob Type: StandardSchedule: Full-timeJob Level: Individual ContributorTravel: Yes, 25 % of the TimeEmployee Status: Regular