2 Clinical Research Quality Officer Jobs in Towson, MD
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Clinical Research Quality Officer
$71k-93k (estimate)
Full Time
2 Months Ago
United Urology Group is Hiring a Clinical Research Quality Officer Near Towson, MD
Job DetailsJob Location
Towson Office - Towson, MD
Position Type
Full Time
Education Level
4 Year Degree
Travel Percentage
Up to 25%
Job Category
Research
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.
Position SummaryThe Quality Assurance (QA) Research Compliance Officer 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
Qualifications Qualifications:
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, and skill level. UUG2
Towson Office - Towson, MD
Position Type
Full Time
Education Level
4 Year Degree
Travel Percentage
Up to 25%
Job Category
Research
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!
Position SummaryThe Quality Assurance (QA) Research Compliance Officer 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.
- Provide advice on corrective action for non-compliance with internal research policies and procedures.
- Assist with Internal Audit and or monitoring as requested by Research Area Directors.
- Complete 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.
Qualifications Qualifications:
- Bachelor’s degree required.
- Minimum of five (5) years clinical research experience.
- Certification in Clinical Research (CCRP/CCRC/CCRA) and/or CHRC.
- Maintained certification of accreditation (CCRC/IATA/CPR/HSP/CITI).
- 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.
- N/A.
- 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.
- 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.
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, and skill level. UUG2
Job Summary
JOB TYPE
Full Time
SALARY
$71k-93k (estimate)
POST DATE
07/29/2024
EXPIRATION DATE
09/23/2024
WEBSITE
unitedurology.com
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