Research Regulatory Coordinator

Arkansas Children’s Hospital; Little Rock (AR); On-site; USD 40,000 - 70,000; Full time

Job summary

Arkansas Children's Hospital is seeking a Regulatory Affairs professional to oversee all regulatory matters for researchers within Arkansas Children's Research Institute. You will ensure compliance with federal/state rules, IRB oversight, and institutional policies governing human subjects research.

The role involves preparing IRB documents, coordinating site initiation visits, and maintaining regulatory drafts with accuracy, while staying compliant with training requirements and collaborating

Qualifications

• Prepares and submits IRB documents under the direction of the PI/Research Administrator.
• Assists with submitting documents and contracts through regulatory and IRB processes.
• Performs high quality review of start-up regulatory forms and associated documentation prior to submission.
• Coordinates and participates in pre-site and site initiation visits and planning of source documents.
• Manages and proofreads updated study regulatory drafts for accuracy and completeness.
• Complies with all Office of Compliance training requirements.
• Communicates review board decisions or compliance issues to researchers and teams.
• Negotiates revisions with researchers and sponsors to facilitate review and approval.
• Attends conferences and participates in study-related meetings.
• Performs other duties as assigned.

Responsibilities

• Prepares and submits IRB documents under PI/Administrator direction.
• Assists with regulatory and IRB submissions and sponsor communications.
• Reviews startup regulatory forms prior to submission to sponsor/IRB.
• Coordinates site initiation visits and planning of source documents.
• Maintains accuracy of regulatory drafts and changes.
• Ensures compliance with training requirements.
• Communicates board decisions and compliance issues to researchers.
• Negotiates revisions to facilitate review board approval.
• Participates in conferences and study-related meetings.
• Performs other duties as assigned.

Skills

IRB knowledge

Regulatory compliance

Documentation review

Communication skills

Education

High school diploma or GED

Bachelor's degree in related field

Certified Clinical Research Professional (CCRP)

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.

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 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.

About Arkansas Children's

Arkansas Children's is the only hospital system in the state dedicated to caring for children, which enables us to uniquely shape the landscape of pediatric care in Arkansas. Arkansas Children's is driven by four core values - safety, teamwork, compassion and excellence which inform every action. Arkansas Children's Hospital has received Magnet Status from the American Nurses Credentialing Center (ANCC), for nursing excellence and patient outcomes. And we are nationally ranked by U.S. News & World Report for Cancer, Cardiology & Heart Surgery, Diabetes & Endocrinology, Nephrology, Neurology & Neurosurgery, Pulmonology & Lung Surgery and Urology. For more than a century, Arkansas Children's has met the unique needs of children. But we're more than just a hospital treating sick kids - our services include two hospitals, a pediatric research institute, foundation, clinics, education and outreach, all with an unyielding commitment to making children better today and healthier tomorrow. Arkansas Children's Little Rock campus includes a 336-bed hospital with the state's only pediatric Level 1 Trauma Center, burn center, Level 4 neonatal intensive care and pediatric intensive care, as well as a nationally-recognized transport service. And Arkansas Children's Northwest provides inpatient and emergency care, clinic rooms and diagnostic services to children in that corner of the state. "Arkansas Children's is a place of hope and comfort for children and parents. When you are at children's, you are part of an elite team united with a common goal of saving children and making their lives better." Michael - Business Operations Manager "Arkansas Children's Hospital is a prestigious institution that cares for children." Linda - Information Systems Analyst "We are an organization of care, love, and hope while we champion children." Angela - Parking and Fleet Coordinator "Care, love, and hope for children!" Kathy - Administrative Assistant "When I think of my time here at Arkansas Children's Hospital, I can honestly say that it has given me a unique perspective on the human condition, and the various roles that we all have in patient care. As a supply assistant, I have a very important job ensuring that the doctors and nurses have what they need to provide the world class medical care to the Children of Arkansas and surrounding states. Being a Champion for Children is more than a catch phrase, it is a way of life!" Nick - Supply Assistant