Research Compliance Specialist Job Description [Updated for 2025]

In the ever-evolving world of research, the role of a Research Compliance Specialist has taken center stage.

As guidelines and regulations continue to develop, the demand for skilled professionals adept at ensuring adherence to these standards grows.

But let’s delve deeper: What’s really expected from a Research Compliance Specialist?

Whether you are:

• A job seeker trying to grasp the core responsibilities of this position,
• A hiring manager outlining the perfect candidate,
• Or simply interested in the complexities of research compliance,

You’re in the right place.

Today, we present a customizable Research Compliance Specialist job description template, designed for effortless posting on job boards or career sites.

Let’s dive right in.

Research Compliance Specialist Duties and Responsibilities

Research Compliance Specialists play a crucial role in ensuring that the research conducted in an organization complies with ethical standards and applicable laws and regulations.

They work closely with various teams in the organization to review research proposals, oversee research activities, and manage compliance issues.

Their duties and responsibilities include:

• Reviewing and evaluating research proposals to ensure they meet ethical and regulatory standards
• Developing and implementing policies and procedures for research activities to ensure compliance with regulations
• Providing guidance and training to researchers on compliance-related issues
• Coordinating with institutional review boards and other regulatory bodies
• Investigating and managing research misconduct allegations
• Maintaining up-to-date knowledge of laws, regulations, and ethical standards in research
• Auditing research activities regularly to identify potential compliance issues
• Providing recommendations to minimize risk and improve compliance in research activities
• Preparing and submitting compliance reports to regulatory bodies
• Managing research data to ensure its integrity and security

 

Research Compliance Specialist Job Description Template

Job Brief

We are seeking a detailed-oriented Research Compliance Specialist to ensure that our research practices meet all pertinent ethical and regulatory standards.

The ideal candidate will possess a keen understanding of research regulations, and be adept at conducting audits, maintaining documentation, and offering guidance on compliance issues.

The Research Compliance Specialist should be able to ensure that research projects align with the organization’s policies, as well as federal and state laws, and help to foster a culture of compliance within the research team.

 

Responsibilities

• Oversee and monitor research activities for compliance with federal, state, and institutional policies.
• Conduct compliance audits and implement corrective actions when necessary.
• Assist with the development and implementation of compliance training programs.
• Maintain updated knowledge of regulations and standards pertaining to research.
• Provide guidance and advice on compliance issues and ethical considerations.
• Prepare, review, and submit regulatory documents.
• Manage record-keeping and documentation systems.
• Communicate and collaborate with various departments within the organization to ensure compliance in research activities.

 

Qualifications

• Proven experience in a similar role in research compliance.
• Knowledge of research regulations and ethical standards.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Detail-oriented with strong organizational skills.
• Bachelor’s degree in law, science, healthcare administration, or a related field.
• Certified in Healthcare Research Compliance (CHRC) is a plus.

 

Benefits

• 401(k)
• Health insurance
• Dental insurance
• Retirement plan
• Paid time off
• Professional development opportunities

 

Additional Information

• Job Title: Research Compliance Specialist
• Work Environment: Office setting with occasional on-site visits to research facilities. Some travel may be required for meetings or audits.
• Reporting Structure: Reports to the Director of Compliance.
• Salary: Salary is based upon candidate experience and qualifications, as well as market and business considerations.
• Pay Range: $65,000 minimum to $95,000 maximum
• Location: [City, State] (specify the location or indicate if remote)
• Employment Type: Full-time
• Equal Opportunity Statement: We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
• Application Instructions: Please submit your resume and a cover letter outlining your qualifications and experience to [email address or application portal].

 

What Does a Research Compliance Specialist Do?

Research Compliance Specialists typically work for research institutions, universities, pharmaceutical companies, or any organization conducting research.

They may also work as consultants providing their expertise to various organizations.

They are responsible for ensuring that all research activities undertaken by an organization comply with applicable regulations, policies, and standards.

These may include ethical guidelines, government regulations, and industry standards.

Their job is to review and approve research proposals to ensure that they meet all necessary compliance requirements.

They are also involved in the development and implementation of compliance policies and procedures, and they conduct audits to identify any areas of non-compliance.

Research Compliance Specialists also provide training and guidance to researchers on compliance matters, such as ethical considerations, data management, and regulatory requirements.

They act as a liaison between the organization and regulatory bodies, responding to any inquiries or inspections and implementing any necessary corrective actions.

In some cases, they may also be involved in risk management activities, assessing potential compliance risks and developing strategies to mitigate these risks.

The Research Compliance Specialist plays a crucial role in ensuring that the organization’s research activities are conducted ethically and legally, maintaining the integrity of the research and protecting the organization’s reputation.

 

Research Compliance Specialist Qualifications and Skills

A proficient Research Compliance Specialist should have the skills and qualifications that align with your job description, such as:

• Thorough knowledge of federal, state, and local compliance laws and regulations related to research activities, with the ability to interpret and apply these laws and regulations.
• Excellent organizational skills to manage, track, and document compliance activities, ensuring that all research activities are compliant with the necessary standards and regulations.
• Ability to conduct risk assessment, identify potential areas of compliance vulnerability, and develop corrective action plans for resolution of problematic issues.
• Excellent communication and interpersonal skills to effectively convey compliance-related issues to research teams, and foster a culture of ethical conduct and commitment to compliance throughout the organization.
• Strong analytical and problem-solving skills to address and resolve potential compliance issues effectively and promptly.
• Attention to detail and accuracy, to ensure that all research activities are carried out in accordance with the established regulations and protocols.
• Ability to work collaboratively with diverse teams, demonstrating adaptability and the capacity to function effectively in a dynamic, complex environment.

 

Research Compliance Specialist Experience Requirements

Entry-level research compliance specialists may have 1 to 2 years of experience, often through an internship or part-time role in research or regulatory compliance.

They can also gain hands-on experience in related roles such as Research Assistant, Compliance Assistant, or Quality Assurance Coordinator.

Candidates with more than 3 years of experience often develop their regulatory understanding and research compliance skills in entry-level Research Compliance or Regulatory Affairs roles.

Those with over 5 years of experience are expected to have extensive knowledge of research protocols, regulations and procedures.

They may also have experience in conducting audits, providing training, and working with research teams to ensure compliance.

Such candidates are often ready for roles that involve overseeing the research compliance program of an organization or institution.

Some roles may require specific certifications such as Certified in Healthcare Research Compliance (CHRC) or Certified in Healthcare Privacy Compliance (CHPC).

Additionally, an advanced degree in a relevant field such as law, healthcare, or science can be beneficial.

 

Research Compliance Specialist Education and Training Requirements

Research Compliance Specialists typically have a bachelor’s degree in law, business administration, healthcare administration, or a related field.

A strong foundational knowledge of research methodologies, ethics, and regulatory affairs is crucial in this role.

They should be well-versed in various compliance laws and regulations pertaining to research, such as Institutional Review Board (IRB) regulations, Good Clinical Practice guidelines, and federal research regulations.

In-depth knowledge in areas such as human subjects protection, animal welfare, biosafety, and conflict of interest is also beneficial.

This can be obtained through relevant coursework or on-the-job training.

Many positions prefer candidates with a master’s degree in healthcare compliance, law, or a related field.

These advanced degrees usually provide more in-depth training on research compliance and regulation.

Certifications such as Certified in Healthcare Compliance (CHC) or Certified in Healthcare Research Compliance (CHRC) are advantageous and can provide evidence of a candidate’s commitment to the field.

Experience in a research setting, especially in compliance or regulatory affairs, is typically required.

This can include experience in conducting audits, developing policies and procedures, and managing compliance programs.

Continuing education is also critical in this role, as regulations and best practices often change.

This can be achieved through workshops, seminars, and professional development courses.

 

Research Compliance Specialist Salary Expectations

The average salary for a Research Compliance Specialist is $68,875 (USD) per year.

However, the actual salary may vary widely depending on factors such as level of experience, industry, and geographical location.

 

Research Compliance Specialist Job Description FAQs

What skills are necessary for a Research Compliance Specialist?

A Research Compliance Specialist should possess strong analytical skills to evaluate and monitor research activities efficiently.

They should also have excellent knowledge of research ethics and regulations.

Good communication skills are essential to interact with researchers and stakeholders.

Attention to detail, organizational skills and the ability to understand and interpret regulatory requirements are also important.

 

What kind of degree does a Research Compliance Specialist need?

Most Research Compliance Specialists need a bachelor’s degree, preferably in a related field like life sciences or law.

An advanced degree or certification in areas such as healthcare compliance, research administration, or legal studies may provide an advantage.

 

What should you look for in a Research Compliance Specialist resume?

A resume for a Research Compliance Specialist should demonstrate a solid understanding of research compliance and regulatory requirements.

Look for a strong background in research, preferably in a related field.

Also, look for experience in preparing reports, conducting audits, and implementing compliance programs.

Certifications related to research compliance or administration are also desirable.

 

What qualities make a good Research Compliance Specialist?

A good Research Compliance Specialist should be detail-oriented and have a thorough understanding of research ethics and regulations.

They should be able to work well under pressure, maintain confidentiality, and interact effectively with various stakeholders.

The ability to interpret complex regulatory language and apply it to various research activities is also crucial.

 

What is the role of a Research Compliance Specialist in research projects?

A Research Compliance Specialist ensures that all research activities comply with applicable laws, regulations, and institutional policies.

They review research protocols, provide guidance on ethical considerations, manage audits and investigations, and facilitate training for research teams.

They also liaise with regulatory bodies and help in the preparation of compliance reports.

 

Conclusion

And there you have it.

Today, we’ve uncovered the real responsibilities of a research compliance specialist.

And guess what?

It’s not just about maintaining compliance.

It’s about shaping the future of research, one compliance guideline at a time.

With our comprehensive research compliance specialist job description template and real-world examples, you’re equipped to take your next step.

But why stop there?

Explore further with our job description generator. It’s your tool for creating precise job listings or perfecting your resume.

Remember:

Every guideline maintained is a part of the bigger picture.

Let’s shape that future. Together.

How to Become a Research Compliance Specialist (Complete Guide)

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