Assistant Compliance Officer

We are looking for an Assistant Compliance Officer who will be responsible for assisting the Compliance Officer in preventing improper conduct of employees, as well as vendors and partners where applicable.

The Assistant Compliance Officer will develop, implement and enforce policies and procedures that reduce the company’s compliance risks and ensure that our organization adheres to ethical standards, laws, and industry regulations, with a particular emphasis on clinical research compliance.

Location: Abu Dhabi, UAE

Salary: 22,000-25,000 AED/month

Skills and Experience

• Bachelor's degree in law, business administration, life sciences, healthcare, or a related field; advanced degree preferred
• Minimum of 5 years of experience in compliance, preferably in a U.S.-based or international setting including UAE. Previous experience in research compliance is highly desirable
• In-depth knowledge of U.S. FDA regulations (21 CFR) and Abu Dhabi DOH regulations related to clinical research is preferred
• Certification in clinical research compliance (e.g., Certified Clinical Research Professional (CCRP) or Healthcare Research Compliance (CHRC)) is highly desirable
• Other relevant professional certifications like Certified Compliance and Ethics Professional (CCEP), Certified Healthcare Compliance (CHC), or Certified Regulatory Compliance Manager (CRCM) are encouraged as well
• Strong analytical, problem-solving, and organizational skills
• Excellent written and verbal communication skills
• Ability to work independently and as part of a multidisciplinary team
• Proficiency in using compliance management software and tools

Key Responsibilities:

Regulatory Compliance:

• Ensure all clinical research activities comply with U.S. FDA regulations, including 21 CFR Parts 50, 54, 56, 312, and 812
• Ensure compliance with Abu Dhabi Department of Health (DOH) regulations, guidelines, and policies
• Ensure compliance by non-clinical staff to all applicable regulations
• Monitor changes in regulatory requirements and update the compliance programs accordingly

Policy Development:

• Work with the Compliance Officer to develop and implement comprehensive compliance policies and procedures for its clinical, research, and non-clinical departments
• Ensure that all policies are regularly reviewed and updated to reflect current regulatory requirements and best practices

Training and Education:

• Provide training to staff on regulatory requirements, ethical standards, and internal policies
• Conduct regular educational sessions to keep staff informed about changes in regulations and compliance best practices

Monitoring and Auditing:

• Work with the relevant department heads and the Compliance Officer to develop and implement monitoring and auditing plans to ensure ongoing compliance with regulatory requirements
• Conduct regular audits of clinical research activities, including informed consent processes, data integrity, and reporting

Investigations and Reporting:

• Assist the Compliance Officer and Head of Legal in conducting investigations into potential compliance violations across the company
• Assist the Compliance Officer and Head of Legal in preparing and submitting regulatory reports and ensuring timely communication with regulatory bodies

Ethics and Oversight:

• Serve as a liaison with Institutional Review Boards (IRBs) and Ethics Committees to ensure ethical conduct of research
• Work with the Compliance Officer and Head of Legal on the informed consent process and ensure that participants' rights and welfare are protected

Documentation and Records Management:

• Ensure accurate and complete documentation of all clinical research activities
• Maintain records in accordance with regulatory requirements and organizational policies

Collaboration:

• Work closely with the various departments across the comany, including the research, clinical, and non-clinical departments to promote a culture of compliance
• Collaborate with external partners, sponsors, and regulatory agencies as needed

About the role:

The Assistant Compliance Officer will play a vital role in ensuring that the company’s operations, particularly in clinical research, adhere to the highest standards of regulatory compliance and ethical conduct. This position involves collaborating with multiple departments, staying updated on regulatory changes, and contributing to the development and implementation of policies and procedures. The ideal candidate will have significant experience in compliance, especially in a healthcare or research setting, and will be equipped with the necessary certifications and skills to drive the organization's compliance initiatives effectively.