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Clinical trials specialist skills for your resume and career

Updated January 8, 2025
5 min read
Quoted experts
Sharolyn Kawakami-Schulz Ph.D.,
Dr. Ionut Florescu
Below we've compiled a list of the most critical clinical trials specialist skills. We ranked the top skills for clinical trials specialists based on the percentage of resumes they appeared on. For example, 12.7% of clinical trials specialist resumes contained patients as a skill. Continue reading to find out what skills a clinical trials specialist needs to be successful in the workplace.

15 clinical trials specialist skills for your resume and career

1. Patients

Here's how clinical trials specialists use patients:
  • Study Manager responsible for educating and informing clinical patients on all aspects of their research participation.
  • Have a very good personality, love working with patients and staff.

2. Clinical Research

Here's how clinical trials specialists use clinical research:
  • Participated on corporate global clinical research meeting and ensured upper management are updated on all relevant issues.
  • Facilitated process improvement initiatives to develop a clinical research database system to manage protocols.

3. Clinical Trials

Here's how clinical trials specialists use clinical trials:
  • Ensured timely, effective completion of clinical trials by maintaining positive relationships with investigators and other members of cross-departmental site team.
  • Collaborated with Vanderbilt University in the development and performance of clinical trials of prosthetic bionic legs for veteran amputees.

4. Informed Consent

Here's how clinical trials specialists use informed consent:
  • Designed country-specific informed consent form templates and reviewed, negotiated, and approved site-specific informed consent forms.
  • Reviewed informed consents to ensure compliance with GCP and organizational guidelines.

5. 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 trials specialists use fda:
  • Followed study specific guidelines and ensured consistent regulatory compliance in accordance with International and FDA guidelines.
  • Identify and report all previously unidentified Adverse Events and Serious Adverse Events in accordance to the protocol and FDA regulations.

6. 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.

Here's how clinical trials specialists use consent forms:
  • Review consent forms to ensure compliance with regulatory requirements.
  • Monitored 1572s, confidentiality/clinical trial agreements and site-specific consent forms for compliance.

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7. Oncology

Oncology is defined as the facet of medicine that deals with cancer. Oncology also deals with the prevention and diagnosis of these diseases. A medical professional who has studied the discipline of oncology is referred to as an ‘oncologist'. An oncologist can further specialize in their discipline and become a medical oncologist, surgical oncologist, or radiation oncologist.

Here's how clinical trials specialists use oncology:
  • Managed study data tracking system using Impact for completeness and accuracy on Oncology study protocol in accordance to project requirements.
  • Negotiated contracts and budgets with Institutions in North America, Europe, and Asia to run oncology investigator sponsored studies.

8. 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 trials specialists use clinical operations:
  • Participate in assigned Clinical Operations initiatives aimed at improving internal standards and systems.
  • Provide site management and regulatory administrative and technical support to clinical operations team.

9. CRO

A CRO (Cathode Ray Oscilloscope) refers to an electrical device usually used in a laboratory to exhibit, measure, and analyze different waveforms of electrical circuits.


CRO may also refer to Conversion Rate Optimization -- the practice of improving a process or product to maximize the number of conversions or sales.

Here's how clinical trials specialists use cro:
  • Collaborate with Sr. Management to determine Delegation of Trial Related Tasks for Country Operations, Headquarters, and the CRO.
  • Plan and conduct study specific training (i.e., CRO training, Investigator Meeting, etc.)

10. TMF

Certain documents, images, and content are required to fulfill the government's requirements on any matter. You can satisfy these regulatory requirements by providing information known as the Trial Master Files. The TMF consists of trial sponsors and participating investigators set of contents that permit the clinical trial to be conducted and attest the trial's collected data.

Here's how clinical trials specialists use tmf:
  • Perform routine quality control (QC) of TMF and submitted documents to ensure overall quality.
  • Manage ongoing collection and quality review of updated essential documents for submission to the TMF.

11. Ich

Here's how clinical trials specialists use ich:
  • Preformed ICF customization in accordance with ICH guidelines, GCP s and local regulatory requirements.
  • Conduct Phase III-IV studies according to Federal Regulations and ICH guidelines.

12. 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.

Here's how clinical trials specialists use gcp:
  • Provided training to site coordinators in GCP, Regulatory Documentation, and various other functional areas.
  • Monitored clinical studies for adherence to protocol, GCP, and company SOPs to ensure timely enrollment against plan.

13. Institutional Review

Here's how clinical trials specialists use institutional review:
  • Submit protocol specific information and clinical documentation to the Institutional Review Board.
  • Prepared and submitted Institutional Review Board applications.

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 trials specialists use data entry:
  • Organized and scheduled study monitor visits to ensure that data entry and charts were up to date.
  • Performed data entry of regulatory documents & maintenance in Clinical Trial Management System (CTMS).

15. Data Management

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.

Here's how clinical trials specialists use data management:
  • Updated electronic data management system with site-specific documents, initiated and approved drug shipments.
  • Assisted Data Management in resolving data discrepancies and missing data.
top-skills

What skills help Clinical Trials Specialists find jobs?

Tell us what job you are looking for, we’ll show you what skills employers want.

What technical skills for a clinical trials specialist stand out to employers?

Sharolyn Kawakami-Schulz Ph.D.Sharolyn Kawakami-Schulz Ph.D. LinkedIn profile

Director, Office of Professional Development, University of Minnesota Medical School

Graduates who possess certain technical skills should be sure to demonstrate in their job documents how those skills meet the needs of an employer. However, more than any particular technical skill, graduates will need to demonstrate their ability to continue to learn and adapt. Communication skills - written, oral, and to various audiences - will continue to be key in their ability to succeed and do well in all sectors.

What soft skills should all clinical trials specialists possess?

Dr. Ionut FlorescuDr. Ionut Florescu LinkedIn profile

Research Professor Financial Engineering, Director Hanlon Laboratories, Director Financial Analytics program, Stevens Institute of Technology

I believe in terms of soft skills, every graduate should be able to explain the results of their complex models to someone who isn't technically sound. So, presentation skills are extremely important. Then the capability of approaching a presenter at a conference or workshop and ask pertinent questions about what they just presented is really important. We require all our students to not only make presentations but also ask questions during other teams' presentations. I believe the most important thing as a teacher in the course is to criticize them when their presentation is not crisp or when the question isn't clear or appropriate.
Do you want to know more?
Read more about what experts have to say about clinical trials specialist

List of clinical trials specialist skills to add to your resume

Clinical trials specialist skills

The most important skills for a clinical trials specialist resume and required skills for a clinical trials specialist to have include:

  • Patients
  • Clinical Research
  • Clinical Trials
  • Informed Consent
  • FDA
  • Consent Forms
  • Oncology
  • Clinical Operations
  • CRO
  • TMF
  • Ich
  • GCP
  • Institutional Review
  • Data Entry
  • Data Management
  • Site Management
  • Clinical Trial Management
  • Study Start-Up
  • CTMS
  • Clinical Studies
  • Project Management
  • CRA
  • Management System
  • Pharmaceutical Industry
  • Site Initiation
  • Clinical Sites
  • Electronic Data
  • Clinical Practice
  • Biomarkers
  • QC
  • Study Sites
  • EDC
  • ICF
  • ICH Guidelines
  • NIH
  • Irbs
  • Site Monitoring
  • Safety Updates
  • Remote Monitoring
  • Contractual Obligations
  • Worksheets
  • Routine Monitoring
  • Query Resolution
  • Trial Support
  • Cdas
  • SRP
  • CRFs

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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