Research Regulatory Coordinator

Summary

This position will oversee all regulatory affairs business for researchers within Arkansas Children’s Research Institute. This individual will support researchers ensuring that research protocols involving human subjects abide by the federal regulation, state codes, IRB oversight standard, and the institutional policies governing human subjects research.

Additional Information

This position will oversee all regulatory affairs business for researchers within Arkansas Children’s Research Institute. This individual will support researchers ensuring that research protocols involving human subjects abide by the federal regulation, state codes, IRB oversight standard, and the institutional policies governing human subjects research.

Required Education

• High school diploma or GED or equivalent

Recommended Education

• Bachelor's degree in a related field of study.

Required Work Experience

• High School Diploma/GED, or 2 years of experience in lieu of a diploma/GED.

Recommended Work Experience

• Required Certifications: Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates

Description

• Prepares and submits IRB documents under the direction of the PI/Research Administrator and prepares regulatory documents to be sent to the Sponsor.
• Affords assistance in submitting documents and contracts through regulatory and IRB processes and approval; may draft various communications with Sponsor.
• Performs high quality review of start-up regulatory forms and associated documentation prior to submission to sponsor, IRB and filing in Regulatory Binders, to assure documents meet all site and sponsor requirements.
• Collaborates and participates in the pre-site and, site initiation visits and Interim Monitoring Visits as required per protocol.
• Planners and designers of source documents for protocols.
• Manages and proofreads updated study regulatory drafts to ensure the accuracy and completeness of changes.
• Utilizes data resources external to research area, as well as develops and facilitates productive working relationships with the study monitors.
• Complies with all Office of Compliance, and any other departmental training requirements.
• Communicates to researchers and research team members review board decisions or compliance issues which may negatively impact the future of their research protocols.
• Negotiates revisions with researchers and sponsors to facilitate research review board consideration and approval to ensure regulatory compliance.
• (Understand the IRB’s operational requirements)
• Communicates to researchers and research team members review board decisions or compliance issues which may negatively impact the future of their research protocols.
• Maintains compliance with research investigators as to provisions and directions given by the review board regarding research protocols.
• Attends and participates in conferences which support the objectives and goals of the specific protocols.
• b. Actively participates in study related meetings.
• c. Participates in educational programs and professional activities to gain knowledge of current trends, practices and developments.

Skills

• Strong organizational skills
• Excellent communication skills
• Ability to work independently and as part of a team
• Knowledge of regulatory requirements and IRB processes

Benefits

• Tobacco-free workplace policy
• Flu vaccines are required

Pay

• Details not specified

Schedule

• Details not specified

Qualifications

• High school diploma or GED or equivalent
• Bachelor's degree in a related field of study.
• 2 years of experience in lieu of a diploma/GED.
• Required Certifications: Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates

Skills

• Strong organizational skills
• Excellent communication skills
• Ability to work independently and as part of a team
• Knowledge of regulatory requirements and IRB processes

Benefits

• Tobacco-free workplace policy
• Flu vaccines are required

Pay

• Details not specified

Schedule

• Details not specified