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Clinical research specialist skills for your resume and career
15 clinical research specialist skills for your resume and career
1. Patients
- Investigated potential mechanisms of stroke generation in ventricular assist patients utilizing immunological assays and electron microscopy.
- Facilitated critical care research activities by assisting in procedural cases for study enrolled patients.
2. Clinical Trials
- Performed Study Coordinator responsibilities for pharmaceutical clinical trials that involved medications for both children and adults with asthma and allergic rhinitis.
- Utilized experience in psychiatric, psychological, and clinical trials research to help develop protocol content and increase study design feasibility.
3. Informed Consent
- Compose and supervise preparation of regulatory documents including updates to the Informed Consent form.
- Created all relevant documents including source, protocol development and informed consents.
4. 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.
- Attract participation in data collection epidemiology studies by actively recruiting and following diverse group of women.
- Work independently collaborating job assignments, performing ethical data collection and source verification.
5. 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.
- Prepared investigator initiated and industry study protocol for IRB review and approval.
- Prepare new trials, continuing trials' applications, and closure of trials for Institutional Review Board (IRB) approval.
6. Research Data
- Corresponded with collaborators, internal and external, to facilitate sharing of biological specimens and research data.
- Involved in collection, compilation, documentation and analysis of clinical research data.
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The administrative process that involves collecting and keeping the data safely and cost-effectively is called data management. Data management is a growing field as companies rely on it to store their intangible assets securely to create value. Efficient data management helps a company use the data to make better business decisions.
- Review data management queries for completeness and accuracy.
- Developed and initiated a project plan for conducting clinical studies in Europe and US; ensured integrity in study data management.
8. 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.
- Ensured availability of all final study documentation in anticipation of a Sponsor or FDA audit.
- Participated in study developments to ensure compliance with FDA regulations and guidelines.
9. GCP
Google Cloud Platform (GCP) is a collection of cloud computing services that allow users to develop, deploy, and operate original applications on the web. GCP carries a cloud computing infrastructure that facilitates it in keeping track of the resources (e.g., storage, processing speed, and power, network connectivity, database queries, etc.) of an application or a website, whenever it is run on the cloud platform.
- Develop study specific training materials targeted at GCP and federal requirements.
- Tracked clinical sites and studies to ensure compliance with GCP's, SOP's and study protocols.
10. 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.
- Performed data entry and tracked critical study metrics into robust databases.
- Perform database management including subject tracking and medical records data entry.
11. Clinical Research Studies
- Performed daily assignments associated with multiple clinical research studies such as positively interacting and recruiting, patient screening, and assessments.
- Recruit and screen potential study participants for multiple clinical research studies aimed at evaluating functionality of the endocrine system.
12. Institutional Review
- Coordinated research progress with the National Institutes of Health, Institutional Review Board and10 varied pharmaceutical companies.
- Worked with the Institutional Review Board for trial compliance.
13. Consent Forms
Consent forms refer to something that a person signs or attests to in order to agree for something that involves them to happen. They are used in various fields and applications. It is a legal document that can have repercussions if forged or denied later. In medical terms, it is the informed consent of the patient agreeing to the medical procedure they are about to undergo in a sound state of mind.
- Obtain sponsor approval of local consent forms and as necessary, negotiates consent form language with sponsor.
- Entered patient data per visit requirements and maintained proper consent forms necessary for patient participation in studies.
14. Clinical Data
- Performed SAE critical data points reconciliation between Safety and Clinical Databases prior to Interim Analyses.
- Evaluate clinical data/information, providing interim and final reports for assigned clinical study.
15. Principal Investigators
A principal investigator is an individual who's responsible for preparing, conducting, and overseeing a sponsored project, research grant, training, contract,or any project in line with the regulations and instituted laws guiding the conduct of a sponsored research. It majorly applies to research projects, and the PI or principal investigator ensures everything is fully supervised to align with the laws of a sponsored research project.
- Communicated discrepancy to study coordinators and Principal investigators via audit report or problem resolution sheet.
- Assisted principal investigators and research staff in reviewing study budget development and research billing plan.
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Ryan Barker
Visiting Instructor, State University of New York at Oswego
What technical skills for a clinical research specialist stand out to employers?
Assistant Professor of Spanish, Foreign Languages Division Coordinator, Faculty Affiliate, Center for Critical Race & Ethnic Studies, Florida Gulf Coast University
What soft skills should all clinical research specialists possess?
Assistant Director, Graduate Education & Career Connections, Morehouse School of Medicine
List of clinical research specialist skills to add to your resume

The most important skills for a clinical research specialist resume and required skills for a clinical research specialist to have include:
- Patients
- Clinical Trials
- Informed Consent
- Data Collection
- IRB
- Research Data
- Data Management
- FDA
- GCP
- Data Entry
- Clinical Research Studies
- Institutional Review
- Consent Forms
- Clinical Data
- Principal Investigators
- Clinical Trial Management
- HIPAA
- Regulatory Compliance
- Electronic Data
- CRFs
- Site Management
- Site Initiation
- QC
- Study Sponsors
- Data Queries
- Data Analysis
- ICH
- EDC
- Clinical Practice
- NIH
- Clinical Research
- PET
- Study Sites
- Worksheets
- IND
- Study Start-Up
- CRO
- Clinical Sites
- IDE
- Vital Signs
- Clinical Operations
- CTMS
- Home Health
- SAEs
- Clinical Study Reports
- TMF
Updated January 8, 2025