Regulatory Compliance Specialist

Job Description

Job Description

About Us:

Flourish Research is where clinical trials thrive. Flourish Research is one of the industry’s most progressive and diversified clinical trial organizations, with strong capabilities across cardiology, metabolic disorders, renal, oncology, CNS, pulmonology, and vaccine research. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! 

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. 

About the Job: 

We are actively hiring a Regulatory Compliance Specialist at our Andersonville, 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.
• Abide by all HIPAA regulations.
• Maintain confidentiality of sponsor and Flourish Research 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 3 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.
• Is 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.
• Ability to solve problems while working closely across departments.
• Assists with developing and implementing key initiatives in the department.
• Assists with identifying and implementing process improvements.
• Seeks out opportunities to help achieve department/company goals.
• Fosters relationships across teams.
• Consistently accomplishes 80% of individual quarterly goals and objectives.
• Assists 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.
• Ability 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, and 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.