Human Subjects Research Compliance Specialist, Research - Clinical Trials, Full Time, Day

Position Summary

Independently, plans, implements, and oversees quality assurance and research compliance programs and partners with Research Operations to advance quality improvement initiatives across the Okonite Research Center. Supports Investigators and the Study Team to ensure compliance with federal, state, and institutional regulations and guidelines from the Food and Drug Administration (FDA), Office for Human Protection (OHRP), and the International Conference on Harmonization Good Clinical Practice (ICH-GCP).

Provides direction to ensure programs and research activities are implemented at the highest standards with emphasis on quality.

About the Role

Education: Bachelor's degree in nursing, Statistics, Healthcare, Business, or a related field required.

Experience: Minimum of 1-year related experience in the field of Quality Assurance clinical research compliance or Clinical Trials Auditing.

Responsibilities

• Supports Investigators and the Study Team to ensure compliance with federal, state, and institutional regulations and guidelines from the FDA, OHRP, and ICH-GCP.
• Provides direction to ensure programs and research activities are implemented at the highest standards with emphasis on quality.
• Collaborates with Research Operations to advance quality improvement initiatives across the Okonite Research Center.

Requirements

• Knowledge of regulatory standards and survey processes.
• Knowledge of quality improvement tools and techniques.
• Excellent oral and written communication skills.
• The ability to gather, analyze, and communicate technical and clinical data.
• Proven interaction and communication (oral, writing, presenting) skills to effectively communicate with hospital staff, physicians, and regulatory agents and work cooperatively with same.
• Demonstrated competence, clinical expertise, and sound professional judgment.
• Ability to use effective time management to set priorities, perform job related responsibilities, and respond to changing workloads and work environment.
• Demonstrated ability to use effective analytical and critical thinking skills to problem-solve, make critical decisions, and meet departmental and organizational needs.
• Attention to details and the ability to perform work accurately, often changing from one task to another without loss of efficiency or composure.

Skills

• Knowledge of regulatory standards and survey processes.
• Knowledge of quality improvement tools and techniques.
• Excellent oral and written communication skills.
• The ability to gather, analyze, and communicate technical and clinical data.
• Proven interaction and communication (oral, writing, presenting) skills to effectively communicate with hospital staff, physicians, and regulatory agents and work cooperatively with same.
• Demonstrated competence, clinical expertise, and sound professional judgment.
• Ability to use effective time management to set priorities, perform job related responsibilities, and respond to changing workloads and work environment.
• Demonstrated ability to use effective analytical and critical thinking skills to problem-solve, make critical decisions, and meet departmental and organizational needs.
• Attention to details and the ability to perform work accurately, often changing from one task to another without loss of efficiency or composure.

Benefits

• Medical/Prescription, Dental & Vision Discount Program (Full Time/Part Time Employees)
• Group Term Life Insurance and AD&D (Full Time Employees)
• Flexible Spending Accounts and Commuter Benefit Plans
• Supplemental Voluntary Benefits (e.g. Short-term and Long-term Disability, Whole Life Insurance, Legal Support, etc.)
• 6 Paid Holidays, Paid Time Off (varies), Wellness Time Off, Extended Illness
• Retailer Retirement Plan
• Tuition Assistance
• Employee Assistance Program (EAP)
• Valley Health LifeStyles Fitness Center Membership Discount
• Day Care Discounts for Various Daycare Facilities

Pay

$90,168.00 - $112,715.20

Schedule

Day (United States of America)