Job Overview

The Clinical Research Regulatory Specialist is responsible for the management of clinical 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 regulatory guidance and direction to all members of the research team to ensure compliance with all applicable policies, procedures and regulations.

The ETP (Experimental Therapeutics program) is the CCBD (Center for Cancer and Blood Disorders) early phase (phase I/II) clinical trial program. ETP offers investigational treatments for children, adolescents, and young adults with recurrent/refractory illness or with a diagnosis that has no reasonable cure. This program works with cooperative groups, consortiums, pharmaceutical (industry) studies, and PI initiated studies. The team member in this position is key to the ETP Regulatory team in the maintenance of clinical trials (compliance, amendments, continuing reviews, and other job essential functions of the regulatory specialist). This position also supports other ETP regulatory team members in the completion of study start up, IND submissions including (IND/IDEs, sINDs, eINDs), IRB submissions and regulatory compliance. The successful applicant will have extensive knowledge of COMIRB processes and background as a regulatory specialist that compliments the needs of the ETP team. Bachelor’s degree in related field or higher required. Certification would be appreciated.

Location: Aurora, CO

Terms: 3 month contract

Contract Rate: $38-40/hour

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 Standard Operating Procedures (SOPs) as needed.
• Submits Adverse Event Reports and Protocol Deviations according to institutional review board and sponsor-specific reporting requirements.
• Assesses current departmental processes and SOPs; provides suggestions for improvement.
• Enters protocol specific data into required IRB and hospital systems.
• Assists research team members in assessing and optimizing departmental workflows. 
• Assists in training/mentoring new staff, providing constructive feedback to other team members 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 Institutional Review Board, organization 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.
• Regularly participates in departmental meetings to discuss the regulatory status of assigned protocols.

Scope

·      Guidelines: Possesses knowledge of and applies the fundamental concepts, practices and procedures within a particular field of specialization.

·      Complexity: Duties and tasks are varied and somewhat complex, but usually involve limited responsibility. Procedures, methods and techniques to carry out work may not be well defined, requiring greater analysis.

·      Decision Making: Has some discretion in making some 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 own function with team members, peers, management, clients and in limited cases, the public. Uses some discretion and independent judgment when information is exchanged, gathered and/or presented. Defers to higher level team members and/or management in many situations.

·      Supervision Received: Works under some supervision, conferring with higher level employees, supervisor and/or manager as needed.

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