Clinical Research Compliance Specialist

Arizona Arthritis and Rheumatology Research, PLLC; Phoenix (AZ); Vor Ort; USD 60.000 - 85.000; Vollzeit

Zusammenfassung

Arizona Arthritis & Rheumatology Associates, P.C. seeks a Clinical Research Compliance Specialist to oversee staff onboarding, credentialing, and training compliance across offices.

The role ensures adherence to SOPs and regulatory requirements while supporting study-specific training and dashboards. Under minimal supervision, you will manage credentials, tracking, and monitoring, collaborate with all departments, and travel to AARACR and affiliate sites as needed.

Qualifikationen

• Associate’s degree or equivalent.
• 2-year experience in clinical research.
• Excellent oral and written communication skills.
• Proficiency in all Microsoft Office computer applications.
• Must have valid driver’s license.

Aufgaben

• Facilitate onboarding and credentialing of research staff and offices.
• Determine training requirements for each staff member and issue training instructions.
• Track training compliance to ensure it is completed for all required staff within 2 weeks.
• Assist staff in-person and remotely with training completion.
• Issue reimbursement to staff members who complete training per each study budget.
• Approve delegation log and training dashboard against study training requirements.
• Maintain the Onboarding Tracking spreadsheet and study training dashboards.
• Monitor credentials expirations to ensure recertification is obtained before coverage lapses.
• Ensure all internal and external staff are fully compliant on all study protocols and SOPs.
• Ensure all internal and external staff have access to all required systems.
• Determine and collect all credentialing requirements for each office.
• Upload documentation to regulatory files.
• Track monitoring visits to ensure sites are prepared and system access and surveys are issued.
• Ensure monitoring action items and follow-up letters are completed and filed in timely manner.
• Perform quality assurance reviews and provide meaningful data metrics.
• Collaborate with all department roles to develop and deploy policies & systems to improve the overall functionality and success of the department.
• Perform additional duties as requested.
• Travel to all AARACR sites and affiliate sites as needed.

Kenntnisse

Excellent communication

Driver's license

Ausbildung

Associate’s degree or equivalent

Tools

MS Office

Jobbeschreibung

Description

Arizona Arthritis & Rheumatology Associates, P.C. is the largest private Rheumatology practice in the United States. The practice has over 60 providers, 15 sites and over 350 employees providing assessment and treatments for our rheumatology patients. Our providers work together to keep patients healthy, and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.

Arizona Arthritis & Rheumatology Associates, P.C. is the largest private Rheumatology practice in the United States. The practice has over 60 providers, 15 sites and over 350 employees providing assessment and treatments for our rheumatology patients. Our providers work together to keep patients healthy, and are recognized for excellence in medicine and for being pioneers in new treatments, ably supported by our Research department.

We are an equal employment opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status or disability.

Our vision is to provide the best Rheumatology care, anywhere and, to balance sustainable operation with the highest possible level of patient care.

We are a seeking an ambitious, friendly, positive, and compassionate Clinical Research Compliance Specialist to join our team.

Under minimal supervision, the Compliance Specialist will ensure all staff of offices involved with clinical research are fully qualified to perform the required duties and compliant with Standard Operating Procedures and regulatory requirements.

Responsibilities

• Facilitate onboarding and credentialing of research staff and offices
• Determine training requirements for each staff member and issue training instructions
• Track training compliance to ensure it is completed for all required staff within 2 weeks
• Assists staff in-person and remotely with training completion
• Issue reimbursement to staff members who complete training per each study budget
• Approves delegation log and training dashboard against study training requirements
• Maintains the Onboarding Tracking spreadsheet and study training dashboards
• Monitor credentials expirations to ensure recertification is obtained before coverage lapses
• Ensure all internal and external staff are fully compliant on all study protocols and SOPs
• Ensures all internal and external staff have access to all required systems
• Determine and collect all credentialing requirements for each office
• Uploads documentation to regulatory files
• Tracks monitoring visits to ensure sites are prepared and system access and surveys are issued
• Ensures monitoring action items and follow-up letters are completed and filed in timely manner
• Performs quality assurance reviews and provides meaningful data metrics
• Collaborate with all department roles to develop and deploy policies & systems to improve the overall functionality and success of the department
• Performs additional duties as requested
• Travel to all AARACR sites and affiliate sites as needed

Learn more about AARA on our website at http://azarthritis.com

Requirements

QUALIFICATIONS

• Associate’s degree or equivalent
• 2-year experience in clinical research
• Excellent oral and written communication skills
• Proficiency in all Microsoft Office computer applications
• Must have valid driver’s license