A Clinical Research Manager is responsible for managing the day-to-day research operations of an organization undertaking clinical trials, usually pharmacological drug testing.
Research Regulatory Coordinator Arkansas Children's Hospital - 3.9 Little Rock, AR Job Details Full-time 17 hours ago Qualifications Filing Mid-level High school diploma or GED Copy editing Clinical research compliance Bachelor's degree Contracts Research administration Participating in conferences Regulatory submission editing and review CCRP Communication with regulatory authorities for clinical trials Technical writing quality assurance Ethical review application preparation 2 years Negotiation Documentation reviews Research compliance quality assurance records management Full Job Description
ARKANSAS CHILDREN'S IS A TOBACCO FREE WORKPLACE. FLU VACCINES ARE REQUIRED. ARKANSAS CHILDREN'S IS AN EQUAL OPPORTUNITY EMPLOYER. ALL QUALIFIED APPLICANTS WILL RECEIVE CONSIDERATION FOR EMPLOYMENT WITHOUT REGARD TO RACE, COLOR, RELIGION, SEX, SEXUAL ORIENTATION, GENDER IDENTITY OR EXPRESSION, NATIONAL ORIGIN, AGE, DISABILITY, PROTECTED VETERAN STATUS OR ANY OTHER CHARACTERISTIC PROTECTED BY FEDERAL, STATE, OR LOCAL LAWS. CURRENT EMPLOYEES
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Work Shift:
Please see job description for details.
Time Type:
Full time
Department:
CC035772
Regulatory Clinical Research Operations 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:
Recommended Certifications:
Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates Description 1. Prepares and submits IRB documents under the direction of the PI/Research Administrator and prepares regulatory documents to be sent to the Sponsor. Assists with submitting documents and contracts through regulatory and IRB processes and approval; may draft various communications with Sponsor. 2. 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. 3. Coordinates and participates in the pre-site and, site initiation visits and Interim Monitoring Visits as required per protocol. Planning and design of source documents for protocols. 4. 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 relationship with the study monitors. 5. Compliance with all Office of Compliance, and any other departmental training requirements. 6. Communicate to researchers and research team members review board decisions or compliance issues which may negatively impact the future of their research protocols. 7. Negotiate revisions with researchers and sponsors to facilitate research review board consideration and approval to ensure regulatory compliance. (Understand the IRB's operational requirements) 8. Communicate to researchers and research team members review board decisions or compliance issues which may negatively impact the future of their research protocols. Monitor compliance of research investigators as to provisions and directions given by the review board regarding research protocols 9. 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. 10. Performs other duties as assigned.
