Regulatory Compliance Specialist

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 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. Equal Employment Opportunity 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. #J-18808-Ljbffr Flourish Research