Regulatory Specialist - Non-Clinical

Position: Clinical Research Regulatory Specialist

Location: Clinton Twp-MI-106-Research (EM0104), MI

Job : 3582

# of Openings: 1

We are looking for a Regulatory Specialist to provide support to our clinical research team and subjects, ensuring regulatory compliance for clinical studies in accordance with Good Clinical Practice, HIPAA, and OSHA.

Job Responsibilities

• Maintain a professional and courteous manner (verbal, written and in appearance) when interacting with staff, sponsors, IRBs, and subjects.
• Make moral and ethical decisions during interaction with patients, sponsor and IRB representatives, physicians and other staff.
• Independently manage workflows.
• Maintain ongoing communication with Director of Research, Research Manager, Principal Investigator/Sub-Investigator, other study personnel and sponsor/CRO per SOPs and as deemed necessary.
• Possess a thorough understanding of the study protocol(s) to answer all questions pertaining to the study posed by monitors or other staff members.
• Maintain confidentiality of patient and/or protocol issues as appropriate and as bound by Confidentiality Agreements between sponsors and other entities.
• Collect and coordinate information and prepare regulatory documentation for submission to IRBs.
• Perform archiving and destruction of records in compliance with regulatory requirements, as well as assisting in the final close-out storage of clinical trial records.
• Participate in educational training seminars on all topics of clinical research.
• Maintain updated CVs and "Clinical Trial Experience" data sheets.
• Prepare for monitoring visits and assist with regulatory issues during the visits.
• Assist in required contract invoicing of trial budgets and request checks for patient compensation.
• Track and control submissions to IRB (Investigational Review Board).
• Follow and maintain GCP in the regulatory processes.
• Maintain regulatory binders for all studies.
• Meet with monitor during visits to review the Regulatory Binder.
• Comply with all HIPAA regulations.
• Perform all duties in a safe and prudent manner.
• Promptly report adverse events to Associate Director of Research, Principal Investigator/Sub-Investigator, sponsor/CRO as deemed necessary and to ensure subject safety.
• Respond to monitor notes and/or emails in a timely manner.
• Assist with maintenance of the clinical trial advertising/recruitment database and telephone communication for scheduling and follow up appointments as needed.
• Other duties as assigned.

Minimum Qualifications

• High School diploma or equivalent certification.
• 3 years of clinical trials experience, as well as an understanding of clinical trials rules and regulations.
• 3 Years of experience in a medical office.
• Ability to learn tasks related to the operation of the facility and assist physicians.
• Thorough understanding of HIPAA.
• Knowledge of ICD-10 and CPI coding, and Mod Med EMA EMR, preferred.
• Ability to maintain strictest confidentiality.
• Ability to prioritize tasks quickly and appropriately.
• Ability to multi-task.
• Meticulous attention to detail.
• Strong organizational skills.

Benefits

• Medical, dental, and vision insurance
• 401k matching
• Company paid life insurance
• Employee assistance program
• Paid time off

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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