Clinical Research Compliance Specialist

Description

Are you interested in making a difference in patient care? Learn about our unique culture of respect, growth, innovation, the best patient care, and how we give back to the community.

At United Urology Group, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care.

• We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff!
• We deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies.
• We offer competitive salaries and a great work/life balance: enjoy your weekends!
• UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!

United Urology Group is regarded as the leading urology network in the country. Our Affiliates include Chesapeake Urology, Arizona Urology—Phoenix & Scottsdale, Arizona Urology—Tucson, Colorado Urology, and Tennessee Urology.

Position Summary:

The Clinical Research Compliance Specialist is responsible for ensuring that all study personnel within UUG are compliant with ICH guidelines, federal regulations, and internal standard operation procedures.

Primary Duties & Responsibilities:

• Assess research operations to evaluate and determine compliance risk.
• Continuation of training and preparations for FDA inspections.
• Conduct internal monitoring review of research staff at all UUG research site locations nationally.
• Conduct a regulatory review of all established studies at all UUG research site locations nationally.
• Perform billing compliance checks.
• Review and confirm Medicare Coverage Analysis for protocols.
• Prepare for Sponsor-initiated audits.
• Assist in FDA inspections.
• Create new protocol templates and all amendments to protocols in CTMS.
• Prepare reports detailing observations, risks, recommendations, and all other compliance actions required.
• Assist with Internal Audit and or monitoring as requested by Research Area Directors.
• Participate in onboarding of new hires, including SOP review.
• Conduct focus training with research staff.
• Present summaries and findings from internal audits to the Research Compliance Committee.
• Perform other office duties as assigned by the Regulatory Manager.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

Qualifications

Qualifications:

• Bachelor’s degree required or equivalent combination of experience, education, and/or certifications
• Minimum of 3-5 years clinical research experience.
• Certification in Clinical Research (CCRP/CCRC/CCRA) and/or CHRC or obtained within one year of hire
• Maintained certification of accreditation (CCRC/IATA/CPR/HSP/CITI).

Knowledge, Competencies & Skills:

• Proficient knowledge of Medical Terminology.
• Strong understanding of FDA clinical trial phases I-IV.
• Strong understanding of GCP, ICH Guidelines, FDA regulations, and regulatory agencies.
• Ability to use a clinical trials management system (CTMS)
• Highly detailed oriented and strong organizational skills.
• Ability to work independently with little supervision.
• Flexible hours and ability to travel to sites nationally.
• Excellent customer service skills.
• Strong written and verbal communication skills.
• Proficient computer software and database skills.
• Strong attention to detail and ability to stay organized.
• Ability to multi-task and work in a fast-paced environment.

Direct Reports:

• N/A.

Travel:

• Travel out of state to all National UUG research locations quarterly
• Out-of-state travel days can, at times, occur on a weekend day, as needed.

Physical Requirements for the Job:

• Regularly required to sit and stand for extended periods.
• Involves standing, sitting, walking, bending, stooping, and twisting.
• Requires full range of body motion, including manual and finger dexterity and eye-hand coordination.
• Occasionally lifts and carries items weighing up to 25 lbs.

Equal Opportunity Employer: United Urology Group and its affiliate practices are an equal opportunity employer. We do not discriminate based on race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation.

The successful candidate(s) for any UUG position will be subject to a pre-employment background check.

Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws.

Benefits - A Best Place to Work

Competitive salary and benefits packages

In addition to competitive salaries, Chesapeake Urology offers:

• Competitive salary
• Health, dental, and vision insurance
• Health savings account
• Flexible spending account
• Dependent care flexible spending account
• Life insurance
• Voluntary short-term and long-term disability
• Tuition reimbursement
• 401K plan with an employer contribution
• Profit-sharing
• PTO accrual
• Corporate discounts
• Paid holiday
• Most positions fall under our normal business hours, Monday to Friday, so your weekends are free!

More specific information on our salary and benefits is available during your employment interview.