Regulatory Compliance Specialist

About the job

We are actively hiring a Regulatory Compliance Specialist at our Chicago, IL site.

Shift: Monday-Friday day shift (40 hours per week)

Location: Onsite

FLSA Classification: Non-Exempt

Compensation: $24.00-$28.00 per hour

Requirements

• Essential Job Functions:
  • Prepare, maintain and provide oversight to all research-related regulatory documents
  • Populate and coordinate the entire process of initial regulatory documents' submission to the IRB, sponsors and state or federal regulatory offices as necessary
  • Compile study information and submit initial, continuing and final reports to the IRB and/or sponsor
  • Prepare applicable submission forms and submit updated documents including but not limited to: Amendments, Addendums, Investigator's Brochures, Safety Information, Form FDA 1572s and informed consent documents
  • Accurately file and maintain all necessary logs within the regulatory binder(s)
  • Assist in and manage the archival of clinical trial documents/records
  • Prepare for monitoring visits and audits
  • Manage and update full-time and contract employee Curricula Vitae and ensure copies of all current and applicable medical/nursing licenses, certifications and other required regulatory documents are on file
  • Absorb all HIPAA regulations
  • Maintain confidentiality of sponsor and CTT trade secrets
  • Create error free written documents and reports (e.g. cover letters, notes-to-file, memos, etc.)
  • Seek additional assignments when other tasks are completed
  • Perform all duties in a time- and cost-effective manner
  • Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors
• Additional duties as assigned by management

Physical Requirements and/or Environmental Factors

• Work is performed in a typical interior office setting
• Local travel required
• Monitor/Sponsor/IRB Customer Service
• Daily computer use
• Occasional evening and weekend work schedules
• Ability to properly lift up to twenty-five pounds and occasionally more than twenty-five pounds
• Ability to drive and daily availability of an automobile

Minimum Requirements

• Bachelor's degree or equivalent experience
• Minimum of 2+ years at CTT plus 103 years' experience within the field of clinical or biological research

Knowledge and Skills

• Exceptional knowledge of clinical research methods
• Consistently demonstrates core values & proficiency of skills set
• Must be experienced with Microsoft office applications (Outlook, Word and Excel) as well as internet-based applications
• Must be detail oriented, organized, self-motivated, be able to work independently and one team, and the ability to stay on task
• Demonstrates excellent interpersonal skills including written and verbal communications
• Moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics and other employees
• Demonstrates professionalism, and a strong work ethic
• Must have the ability to adapt and take on additional tasks as requested
• Able to solve problems while working closely across departments
• Absists with developing and implementing key initiatives in the department
• Absists with identifying and implementing process improvements
• Fosters relationships across teams
• Consistently accomplishes 80% of individual quarterly goals and objectives
• Absists with training and mentoring department new hires
• Demonstrates good critical thinking and decision-making skills resulting in sound judgement
• Industry certified as applicable
• Demonstrated ability to collaborate and align with operations
• Flexible and able to multi-task and prioritize competing demands
• Able to think independently and influence when appropriate

Benefits

• Health, dental, and vision insurance plans
• 401(k) with a 100% employer match on the first 4% of employee contributions
• Tuition reimbursement
• Parental leave
• Employee referral program
• Employee assistance program
• Life insurance
• Disability insurance
• A generous PTO plan covering vacation, sick, personal days and 8 paid holidays

Flourish Research is an equal employment opportunity employer

Employment decisions are based on merit and business needs, and not on race, color, sex (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees.