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Clinical trials associate skills for your resume and career

Updated January 8, 2025
6 min read
Quoted expert
Sharolyn Kawakami-Schulz Ph.D.
Below we've compiled a list of the most critical clinical trials associate skills. We ranked the top skills for clinical trials associates based on the percentage of resumes they appeared on. For example, 9.4% of clinical trials associate resumes contained informed consent as a skill. Continue reading to find out what skills a clinical trials associate needs to be successful in the workplace.

15 clinical trials associate skills for your resume and career

2. Patients

Here's how clinical trials associates use patients:
  • Performed database lock activities for a Phase I-IV clinical trial study for oncology and psychiatric 1600+ patients with Alzheimer's disease.
  • Interview and evaluate all patients being screened for entry into available clinical trials or treatment plans, assessing their eligibility.

3. 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 associates use clinical operations:
  • Contributed to site feasibility and the identification /selection of qualified investigators and study sites in collaboration with Global Monitoring/Clinical Operations.
  • Communicated effectively across functional departments with Clinical Operations.

4. 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 associates use fda:
  • Work collaboratively with managers during FDA inspections and readiness processes.
  • Maintain regulatory documents for FDA and research sponsor

6. 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 associates use tmf:
  • Participated in department initiatives including: templates for meeting minutes, site payments, start-up documents and TMF audits.
  • Participate in DIA TMF Reference Model meetings and initiatives to gain TMF-related knowledge implement industry standards and best practices.

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7. 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 trials associates use irb:
  • Maintained research records and updated protocols with university IRB.
  • Assist with the preparation of FDA-required regulatory submissions to Central Institutional Review Board (IRB) and local IRB.

8. Meeting Minutes

Here's how clinical trials associates use meeting minutes:
  • Assisted Project Manager and project team with Investigator Meeting coordination, activities preparation and generated meeting minutes.
  • Prepared and distributed meeting minutes and agendas for various meetings and teleconferences.

9. Ich

Here's how clinical trials associates use ich:
  • Maintained Good Clinical Practice in compliance with ICH guidelines.
  • Applied working knowledge of a therapeutic area ICH Guidelines, GCP's and SOPs.

10. 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 associates use gcp:
  • Maintained and coordinated the logistical aspects of clinical trial projects according to GCP and relevant SOP's.
  • Maintained the quality and completeness of study master files across programs in compliance with GCP.

11. 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 associates use cro:
  • Worked collaboratively with CRO partners and also directly with site personnel to insure successful communication and facilitation of clinical trials.
  • Participated in CRO Oversight activities such as generation and/or distribution of study specific documents and tools.

12. 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 associates use oncology:
  • Coordinated and managed clinical data for 12 oncology clinical trials.
  • Participate as Lead CTA on Study Launch Team piloting on Oncology therapeutic area studies and specializing in study start up.

13. Study Start-Up

A study-start up serves as the foundation of every clinical study, and it helps determine the success of every project. The study start-up is also the stage where the clinical data manager negotiates with sponsors and other business partners, developing comprehensive plans for the study.

Here's how clinical trials associates use study start-up:
  • Work with teams during all phases of clinical trials including study start-up, conduct and close-out.
  • Assist with study start-up, maintenance and close out of pharmaceutical clinical trials.

14. 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 trials associates use data collection:
  • Reviewed and supported proposed modification of feasibility data collection spreadsheet template for individual feasibility studies.
  • Improved data collection for clinical trial protocols to reduce data inaccuracies and protocol deviations.

15. Clinical Trial Management

Here's how clinical trials associates use clinical trial management:
  • Ensured accuracy of clinical trial management databases and resource/budget tracking tools.
  • Provided advanced, diversified and confidential clinical trial support to Head of Clinical Development and the Clinical Trial Management Team.
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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.

List of clinical trials associate skills to add to your resume

Clinical trials associate skills

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

  • Informed Consent
  • Patients
  • Clinical Operations
  • FDA
  • Consent Forms
  • TMF
  • IRB
  • Meeting Minutes
  • Ich
  • GCP
  • CRO
  • Oncology
  • Study Start-Up
  • Data Collection
  • Clinical Trial Management
  • QC
  • CTMS
  • Data Entry
  • Data Management
  • Clinical Project
  • EDC
  • Study Sites
  • Clinical Data
  • Clinical Sites
  • CRFs
  • Site Selection
  • SharePoint
  • IND
  • Clinical Study Reports
  • Pharmaceutical Industry
  • Institutional Review
  • Management System
  • IV
  • Safety Reports
  • Site Initiation
  • CRAs
  • Routine Monitoring
  • Clinical Documentation
  • Patient Enrollment
  • Clinical Research Studies
  • Status Reports
  • Investigative Sites
  • ICF
  • External Vendors
  • Team Training
  • Cdas
  • Biomarkers
  • Trial Support

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.

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