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Clinical trials associate skills for your resume and career
15 clinical trials associate skills for your resume and career
1. Informed Consent
- Develop study related manuals, laboratory documents and template informed consent forms.
- Facilitate patient and family understanding of the protocol and informed consent.
2. 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.
- 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.
- Work collaboratively with managers during FDA inspections and readiness processes.
- Maintain regulatory documents for FDA and research sponsor
5. 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.
- Negotiated content of consent forms signed by participants in a clinical research trial.
- Monitored 1572s, confidentiality/clinical trial agreements and site-specific consent forms for compliance.
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.
- 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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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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
Director, Office of Professional Development, University of Minnesota Medical School
List of clinical trials associate skills to add to your resume
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