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Clinical research monitor skills for your resume and career

Updated January 8, 2025
4 min read
Below we've compiled a list of the most critical clinical research monitor skills. We ranked the top skills for clinical research monitors based on the percentage of resumes they appeared on. For example, 11.6% of clinical research monitor resumes contained fda as a skill. Continue reading to find out what skills a clinical research monitor needs to be successful in the workplace.

15 clinical research monitor skills for your resume and career

1. 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 clinical research monitors use fda:
  • Conducted initiation visits to train site personnel and monitoring visits to ensure adherence to FDA regulations and study protocol requirements.
  • Reviewed study related processes relative to applicable regulatory requirements, including the FDA's GCP regulations and departmental guidelines.

2. Clinical Trials

Here's how clinical research monitors use clinical trials:
  • Audit investigator and protocol level file periodically for quality assurance and ensuring up to date clinical trial information.
  • Trained investigators and study staff on documentation of clinical trial activity, protocol compliance and regulatory requirements.

3. Informed Consent

Here's how clinical research monitors use informed consent:
  • Write and develop data and tracking forms, informed consent documents, and updating/modifying operating procedures.
  • Performed protocol required clinical assessments, informed consents, determine eligibility of subjects for protocols and maintain adherence to protocol requirements.

4. 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 clinical research monitors use irb:
  • Prepared high quality site documents and collected country-specific information for IRB processes.
  • Developed quality metrics and tools for CTRO, complying with Institutional Review Board (IRB) and state/federal regulations.

5. ICH-GCP

Here's how clinical research monitors use ich-gcp:
  • Ensured ICH-GCP, local & Global SOP s including the Clinical Trial monitoring plan are followed regarding Study conduct.

6. Clinical Operations

Clinical operations caters to the administration of the drug development process by ensuring there is proper planning, appropriate conduct through the process, safety of patients and use of quality data. It also encompasses facilitating effective communication between the different study sites and sponsors of the drug process.

Here's how clinical research monitors use clinical operations:
  • Represent Clinical Operations on several committees and task forces during the implementation of new processes and reorganizations of functional departments.
  • Help facilitates information flow between all members of the clinical operations/clinical trial project team both domestic and globally.

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7. Clinical Practice

Here's how clinical research monitors use clinical practice:
  • Assured adherence to ICH guidelines and Good Clinical Practice, investigator integrity, compliance with protocol and all study procedures.
  • Conduct ongoing Good Clinical Practice training and clinical research education for 16 site nurse research coordinators.

8. Electronic Data

Here's how clinical research monitors use electronic data:
  • Conducted multiple training for both sub-investigators and coordinators (Protocol and Electronic Data Capture database).
  • Train Investigators and clinical study staff on study procedures outlined in protocol and Electronic Data Capture Completion Guidelines.

9. Study Sites

Study sites are areas designated for individuals to carry out their research and to study. These sites can either be a library, a university, a clinical research center, hospitals or other research institutes. These centers are designed specifically to allow scholars and students access to a vast literature through books, encyclopedias, technology and laboratory equipment. Usually, such sites are government-owned property and are open for people of all ages to help them acquire information or carry out a research analysis.

Here's how clinical research monitors use study sites:
  • Assured timely availability of study materials at study sites.
  • Maintained and managed regulatory documents at study sites.

10. Site Monitoring

Here's how clinical research monitors use site monitoring:
  • Represent the Site Monitoring Group as a field liaison to therapeutic area specific projects.
  • Provide training to monitors within the Site Monitoring Group, based on need.

11. Data Collection

Data collection means to analyze and collect all the necessary information. It helps in carrying out research and in storing important and necessary information. The most important goal of data collection is to gather the information that is rich and accurate for statistical analysis.

Here's how clinical research monitors use data collection:
  • Coordinated study visits including scheduling, administering medical screening, and data collection materials preparation for the study subjects and clinicians.
  • Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.

12. Clinical Trial Management

Here's how clinical research monitors use clinical trial management:
  • Provided instruction to internal and external (vendor) team members regarding the fundamentals of clinical trial management and regulatory requirements.
  • Provided training and education to internal and external team members regarding the expectations for clinical trial management and regulatory compliance needs.

13. Site Initiation

Here's how clinical research monitors use site initiation:
  • Performed site initiation, interim site visits and site closures during the clinical trial.
  • Study stages handled: Site Initiation visit and Interim Monitoring visits.

14. Data Entry

Data entry means entering data into a company's system with the help of a keyboard. A person responsible for entering data may also be asked to verify the authenticity of the data being entered. A person doing data entry must pay great attention to tiny details.

Here's how clinical research monitors use data entry:
  • Supervised and analyzed data and information inputted by data entry to ensure accurate transfer of information and prepared clinical research reports.
  • Generate data queries based on validation checks or errors and omissions identified during data entry to resolve identified problems.

15. CRA

The Community Reinvestment Act - CRA is a federal law that encourages federal reserves, financial institutions - certain insured custodians, savings banks, and other lenders to meet the borrowing needs of borrowers in all segments of the community.

Here's how clinical research monitors use cra:
  • Acted as Lead Field CRA reporting to Field CRA Line Manager.
  • Received Veritude CRA Associate of the Quarter- Gold Award
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List of clinical research monitor skills to add to your resume

Clinical research monitor skills

The most important skills for a clinical research monitor resume and required skills for a clinical research monitor to have include:

  • FDA
  • Clinical Trials
  • Informed Consent
  • IRB
  • ICH-GCP
  • Clinical Operations
  • Clinical Practice
  • Electronic Data
  • Study Sites
  • Site Monitoring
  • Data Collection
  • Clinical Trial Management
  • Site Initiation
  • Data Entry
  • CRA
  • Federal Regulations
  • ICH Guidelines
  • Data Management
  • Institutional Review
  • Remote Monitoring
  • Worksheets
  • Clinical Sites
  • Clinical Investigators
  • CRF
  • IND
  • IV
  • Study Procedures
  • CTMS
  • Clinical Research Studies
  • Clinical Data
  • BMS
  • Drug Accountability
  • EDC
  • CRO
  • Investigational Product
  • ICF
  • Routine Monitoring
  • Site Management
  • Expense Reports
  • Data Queries
  • Clinical Study Reports
  • SAEs
  • Investigational Sites
  • Dsmb

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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