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Clinical Research Regulatory Specialist Sr.

Company: Children---s Hospital Colorado
Location: Aurora
Posted on: July 16, 2019

Job Description:

Job Description Why Work at Children's.... Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years. Founded in 1908, Children's Colorado is a leading pediatric network entirely devoted to the health and well being of children. Continually recognized as one of the nation's outstanding hospitals by U.S. News & World Report, Children's Colorado is known both for its nationally and internationally recognized medical, research and education programs as well as the full spectrum of everyday care for kids throughout Colorado and surrounding states. With more than 1,000 healthcare professionals representing the full spectrum of pediatric specialties, Children's Colorado Network of Care includes its main campus, 16 Children's Care Centers and more than 400 outreach clinics. A career at Children's Colorado will challenge you, inspire you, and motivate you to make a difference in the life of a child. Additional Information Department: CCBD Research Center Hours per week: 40, eligible for benefits Shift: Monday - Friday, 8am to 4:30pm Job Overview The Center for Cancer and Blood Disorders (CCBD) is seeking Clinical Research Regulatory Specialists for our nationally ranked Center in the Children's Hospital Colorado. We treat all oncological and hematological disorders with outstanding programs in Neuro-Oncology, the latest Experimental Therapies, and rapidly expanding Bone Marrow Transplant and Cell Therapy programs. Our team-based environment of dedicated and motivated staff and faculty is leading pediatric cancer care. Our ideal candidates are detail-oriented with clinical research experience in pediatric populations. If you are a dedicated, experienced team player looking for meaningful work that changes lives, we want to hear from you. The Senior Clinical Research Regulatory Specialist is responsible for the management of complex research protocol documents and activity from initial submission through study closure. The primary focus is on the development, submission, maintenance, filing and reporting of regulatory documents while achieving and maintaining compliance with all internal, external and federal policies and regulations that apply to research involving human subjects. Provides advanced regulatory guidance and direction of complex matters to all members, including to less experienced Regulatory Specialists, of the research team at Children's Hospital Colorado to ensure compliance with all applicable policies, procedures and regulations. Responsibilities POPULATION SPECIFIC CARE - No direct patient care. ESSENTIAL FUNCTIONS An employee in this position may be called upon to do any or all of the following essential functions. These examples do not include all of the functions which the employee may be expected to perform. - Independently develops and submits Study Institutional Review Board (IRB) documents such as consent forms and protocols for initial submissions, protocol amendments, and continuing reviews. - Independently maintains appropriate study documentation including regulatory binders and enrollment logs. - Responsible for preparing, maintaining and updating regulatory binders for review by internal or external monitoring/auditing groups; available to auditors and monitors to discuss regulatory issues at each visit; able to explain internal regulatory processes and SOPs as needed. - Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements. Serves as a subject matter expert on reporting requirements. - Works closely with investigators in the preparation and submission of Investigational New Drug (IND) applications to the U.S. Food & Drug Administration (FDA). - Serves as a departmental subject matter expert for guidance on IRB communications and related regulatory matters. - Contributes to department wide training on research regulatory requirements. - Leads the development, improvement and implementation of departmental standard operating procedures and study specific processes. Evaluates team members' suggestions to improve processes and Standard Operating Procedures (SOPs). - Enters protocol specific data into required IRB and Children's Hospital Colorado systems. - Assists research team members in assessing and optimizing departmental workflows. - Serves as an expert for training/mentoring other team members, providing constructive feedback as necessary. - Maintains understanding of the professional guidelines and code of ethics related to clinical research conduct, and maintains ability to summarize and clarify these for study teams. - Maintains study compliance with IRB, CHCO and other policies. - Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies. - Communicates clearly and in a professional manner with study teams, sponsors and IRB including timely communication when revisions or changes have been approved. - Recognizes when others need to be included in conversations and escalates appropriately. - Works closely with sponsors and study teams on the preparation of regulatory documents and addressing relevant regulatory issues. - Acts as an expert regulatory resource for other team members and principle investigators. Other Information SCOPE & LEVEL Guidelines: Possesses and applies a broad knowledge of concepts, practices and procedures within a particular field of specialization. Complexity: Duties and tasks are broad and complex, usually requiring a greater degree of responsibility. Procedures, methods and techniques to carry out work may not be well defined, requiring advanced knowledge in specific specialties and of the organization. Decision Making: Has latitude in making most decisions. Decisions and recommendations are made after contemplative analysis and with independent judgment and ingenuity. May escalate the most complex and important decisions to a higher level employee, supervisor and/or manager. Communication: Communicates explanatory and/or interpretive information relative to the organization and/or advanced knowledge of own function with team members, peers, management, clients and in some cases, the public. Uses discretion and independent judgment when information is exchanged, gathered, defended and/or presented. Defers to higher level team members and/or management only when necessary. Supervision Received: Works under limited supervision and with a high degree of independence, conferring with supervisor and/or manager on unusual matters. May be assisted by lower level employees. Qualifications - Education: Bachelor's degree in a related field is required. - Experience: Minimum of five (5) years of related experience is required. - Equivalency: Minimum of nine (9) years of related experience may be considered in lieu of minimum requirements. Physical Requirements Ability to Perform Essential Functions of the Job - Vision - Near: Clear vision at 20 inches or less - Weight Lifted/Force Exerted: up to 10 pounds/4.5 kilos, up to 1/3 of time - Hearing: Able to clearly hear details - Sit: 2/3 or more of time - Talk: Able to communicate verbally - Mental/Emotional: Able to work in close proximity to others and/or in a distracting environment - Mental/Emotional: Able to cope with stress effectively - Mental/Emotional: Able to prioritize effectively Work Environment - Mental/Emotional: Able to tolerate ambiguity - Mental/Emotional: Able to prioritize effectively - Mental/Emotional: May be subject to many interruptions - Office Work Environment: Regular/frequent exposure - Bloodborne Pathogen Category 2: Occasional exposure to blood/body fluid Equal Employment Opportunity It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law or regulation. Be aware that none of the questions are intended to imply illegal preferences or discrimination based on non-job-related information.

Keywords: Children---s Hospital Colorado, Aurora , Clinical Research Regulatory Specialist Sr., Healthcare , Aurora, Colorado

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