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Research compliance specialist skills for your resume and career

Updated January 8, 2025
4 min read
Quoted expert
Elisha Blankson
Below we've compiled a list of the most critical research compliance specialist skills. We ranked the top skills for research compliance specialists based on the percentage of resumes they appeared on. For example, 11.1% of research compliance specialist resumes contained human subjects as a skill. Continue reading to find out what skills a research compliance specialist needs to be successful in the workplace.

15 research compliance specialist skills for your resume and career

1. Human Subjects

Human subjects are human beings used in research studies, which may be medical or non-medical and involve a researcher intervening or only observing. The test may be conducted to determine the effectiveness of a particular drug, a person's reaction to a medical device, or an observation of a person's reaction to waiting in a room for a long period of time.

Here's how research compliance specialists use human subjects:
  • Audit investigators on an annual basis for compliance with any human subjects protocols or exemptions.
  • Maintain human subject training compliance for the institute.

2. Research Compliance

Here's how research compliance specialists use research compliance:
  • Assisted in training UMB researchers (faculty, staff and trainees) in research compliance and the responsible conduct of research.
  • Assisted in researching, assembling and disseminating information on all areas of research compliance to the campus research community.

3. IRB

An institutional review board (IRB), is a form of committee that applies research ethics by vetting research procedures to ensure they are ethical. In order to decide whether or not research can be undertaken, they often perform a kind of risk-benefit analysis. The IRB's function is to ensure that adequate safeguards are in place to protect the interests and health of humans who are participants of a research sample.

Here's how research compliance specialists use irb:
  • Increased investigator/research staff support meetings across departments/divisions; for protocol and consent form development, IRB questions and education.
  • Provided guidance to research faculty, staff and IRB members concerning IRB regulations, compliance and procedures.

4. Clinical Research

Here's how research compliance specialists use clinical research:
  • Update and maintains the database for all clinical research application approved by the Department.
  • Supervised clinical research assistants/coordinators and laboratory technicians.

5. Federal Regulations

Federal regulations refer to the set of rules, both general and permanent that are published in the Federal Register by the agencies of the federal government and the executive departments. Federal regulations are the large body of rules that govern federal practice. Examples of these laws include taxes and financial regulation, discrimination law, wages law, and so on.

Here's how research compliance specialists use federal regulations:
  • Investigate and suspend animal use research in accordance with federal regulations.
  • Conduct basic Compliance duties to ensure staff is compliant with Federal Regulations, Best Practices, and Institutional Policies and Procedures.

6. Informed Consent

Here's how research compliance specialists use informed consent:
  • Determined patient study eligibility, obtained informed consent, and initiated patient randomization and enrollment.
  • Conducted patient screening and enrollment, obtained informed consents and maintained regulatory documents; oversaw accountability.

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7. Clinical Trials

Here's how research compliance specialists use clinical trials:
  • Worked independently in management of large number of simultaneous budget and clinical trial agreement negotiations.
  • Developed and established quality assurance programs regarding the conduct of clinical trial auditing/monitoring.

8. Research Community

Here's how research compliance specialists use research community:
  • Provide assistance to the research community in understanding complex sponsor terms and conditions associated with prospective awards.
  • Developed research development outreach activities to promote interdisciplinary research and networking for the USF research community.

9. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how research compliance specialists use fda:
  • Developed and implemented standard operating procedure for the compliance specialists that ensured FDA compliance and regulations are tracked and followed.
  • Maintain a regulatory notebook in accordance with FDA and State agency procedures and records retention requirements.

10. Institutional Policies

Here's how research compliance specialists use institutional policies:
  • Communicated and interpreted institutional policies to research staff and faculty.

11. Institutional Review

Here's how research compliance specialists use institutional review:
  • Participated in monthly Institutional Review Board meetings.
  • Prepared regulatory documents to Moffitt Scientific Review Committee and the University of South Florida Institutional Review Board.

12. State Laws

Here's how research compliance specialists use state laws:
  • Reviewed recently enacted state laws and regulations affecting insurer's products and business practices to ensure product and advertisement compliance.
  • Determined eligibility for public assistance benefits within designated time frames as required by Federal and State laws.

13. Research Administration

Research administration is concerned with enhancing the success of the research department in any organization by obtaining external funding solely for research, training, and service activity to assist the research department and the organization as a whole.

Here's how research compliance specialists use research administration:
  • Ensured effective operations of Research Administration by articulating professionally and utilizing sound judgment and time management to get the job done.
  • Served as Chairperson on a focus group to develop an informational website pertaining to research administration issues for department administrators.

14. Training Sessions

Here's how research compliance specialists use training sessions:
  • Developed educational training sessions geared towards data collection and management procedures.
  • Arranged staff and faculty training sessions according to department specifications.

15. Human Research

Here's how research compliance specialists use human research:
  • Assisted in the regulatory oversight and organizational review of the Human Research Protections Program at UMB.
top-skills

What skills help Research Compliance Specialists find jobs?

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What type of skills will young research compliance specialists need?

Elisha BlanksonElisha Blankson LinkedIn profile

Program Director NCCU, Assistant Professor, North Carolina Central University

Graduates will need a skill set about the field in which they received training and additional skills useful to the job market. For example, with the changing demographics in the United States, extra skills in information technology and foreign languages will be a plus when entering the job market.
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Read more about what experts have to say about research compliance specialist

List of research compliance specialist skills to add to your resume

Research compliance specialist skills

The most important skills for a research compliance specialist resume and required skills for a research compliance specialist to have include:

  • Human Subjects
  • Research Compliance
  • IRB
  • Clinical Research
  • Federal Regulations
  • Informed Consent
  • Clinical Trials
  • Research Community
  • FDA
  • Institutional Policies
  • Institutional Review
  • State Laws
  • Research Administration
  • Training Sessions
  • Human Research
  • HIPAA
  • Office Procedures
  • Research Studies
  • Regulatory Compliance
  • GCP
  • Research Projects
  • NIH
  • Internal Audit
  • Regulatory Agencies
  • Clinical Practice
  • Sops
  • Billing Compliance
  • OFAC
  • QA
  • PowerPoint

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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