Research Regulatory Coordinator II

Overview:

The Research Regulatory Coordinator II supports the mission and goals of the DHMC research program. This position is responsible for independently managing study tasks primarily related to working with IRBs and study sponsors. This position works with study teams and research administration. Works interactively with regulatory committees

Responsibilities:

• Record Management - Assists with creating, compiling, and maintaining essential records and documents required by DHMC and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations including timely IRB submissions meeting sponsor and departmental requirements.

• Develop Reports - Gathers information regarding all pertinent activity related to the protocol, including safety and protocol compliance information, within established guidelines.

• Resolving Sponsor & Regulatory Issues – Supports the resolution of regulatory and sponsor-related issues and maintains current knowledge to be able to function as a resource to the IRB and study team on regulatory and sponsor-related issues.

• Sponsor Communication - Communicates with sponsors in an accurate and timely manner regarding the status of research studies.

• Investigator Interaction - Maintains understanding of processes for conducting investigator- sponsored studies at DHMC and helps investigators, including trainees, in submitting and maintaining individual research projects protocols and required approvals.

• Subject Matter Expertise - Continues to develop knowledge of departmental, IRB (Local and commercial), and institutional processes and helps to ensure that clinical research activities are conducted in compliance with applicable FDA, OPHR, ICH, JC, and other regulatory guidelines.

• Storage and Tracking of Study Records - Maintains and tracks on-site and off-site storage of required study records and performs data entry for accurate use of a tracking system for maintaining required essential documents .

• Compliance of Ongoing Activities - Under direction of supervisor, collaborates with the IRB and departments to ensure that clinical research activities are conducted in compliance with applicable FDA, OHRP, ICH, JC, and other regulatory guidelines.

• Relationships with Sponsor Organizations - Assists in maintaining positive and productive relationships with sponsor organizations. May facilitate site visits as assigned, and ensures action items noted during site visits are completed and closed.

• Maintains essential documents - Properly utilize and maintains the system to store and track required essential regulatory documents according ICH Good Clinical Practice (GCP) guidelines including but not limited to: investigators’ CVs, medical licenses, CITI training, clinical laboratory certifications, etc.

• Tracking study progress for compliance purposes - Uses applicable clinical trial management system(s) to review clinical trials data to update departmental leadership on compliance activities.

• Informed Consent Development – Under direction of supervisor and senior regulatory team members, develops local informed consent documents based on sponsor templates, institutional requirements, and a basic understanding of the concepts of plain language and healthcare literacy.

• Other duties as assigned

Qualifications:

• Bachelors or equivalent years of experience

• 2 years of relevant research experience

• Ability to travel as required

• SOCRA/ACRP Certification or eligible for certification preferred

Required Licensure/Certifications: