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Clinical research associate skills for your resume and career

15 clinical research associate skills for your resume and career
1. Patients
- Chart review of patients undergoing angioplasty procedures or other admitting diagnoses at the MedStar Washington Hospital Center per current review requirements/request.
- Monitored and summarized computer based reports of patients enrolled and forms received and report to data analyst and study coordinator.
2. Informed Consent
- Proofread FDA /Informed Consent Forms and collected soft copies of personnel certifications/disclosure agreements while maintaining all documentation within the company database.
- Provided detailed information to eligible patients in an effort to obtain informed consent to enrollment, and subsequently filed appropriate paperwork.
3. 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.
- Served as a CRA with provider of outsourced development services to pharmaceutical and biotechnology industries.
- Worked with management on monitoring strategy, and/or developing project-specific CRA training.
4. Clinical Trials
- Support the site identification process and evaluate potential qualified investigators and clinical sites for suitability to participate in the clinical trials.
- Managed and monitored inpatient and outpatient clinical trials, including identifying and resolving site issues, protocol compliance and regulatory issues.
5. Clinical Trial Management
- Maintain clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor.
- Perform data entry of regulatory documents and maintenance of Investigator information in the Clinical Trial Management System
6. 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.
- Develop and implement research policies and procedures and provide in-service training presentations to the Pediatric Hematology/Oncology nursing staff to ensure compliance.
- Recruited and screened potential candidates for clinical trial eligibility in the fields of children's oncology and hematology.
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Build a professional clinical research associate resume in minutes. Our AI resume writing assistant will guide you through every step of the process, and you can choose from 10+ resume templates to create your clinical research associate resume.7. 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.
- Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.
- Key Responsibilities:Manage clinical research projects assigned:on-site monitoring and data collection, assist protocol and CRF development
8. 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.
- Review approved/acknowledged information submitted to IRB as needed for thorough understanding of study expectations and updates.
- Interacted with IRB officials, project management and investigators to ensure compliance and accuracy of documentation.
9. Ich
- Implemented and monitored clinical trial to ensure sponsor/investigator obligations were met and were compliant with applicable local requirements and ICH guidelines.
- Performed investigative site file reconciliation and reviewed essential documents for accuracy, consistency and compliance with ICH guidelines and sponsor requirements.
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.
- Supervised and trained research assistants in interpretation of complex medical data, laboratory procedures, and GCP compliance
- Verified site suitability, subject inclusion/exclusion, IP accountability and GCP adherence.
11. 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.
- Conducted qualification, initiation, interim and close-out monitoring visits in compliance with good clinical practices and FDA regulations.
- Recruited new physician investigators and inspected their offices, audited and processed regulatory documentation for submission to the FDA.
12. 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.
- Reviewed data listings and assisted data management with query generation and sites with query resolution in preparation for database lock.
- Run Validated edit checks programs: Maintain knowledge of current regulations and technologies related to Data Management and Study related Standards
13. Site Management
Site Management is the process of managing the operations of a site for a construction project. The tasks of managing a site include conducting health and safety inspections, installing facilities and offices before project commencement, and communicating construction progress to clients. Good site management requires sound knowledge of construction processes.
- Administered clinical research projects; recruit investigators, collect investigator documentation, site management, and prepare monthly status reports.
- Performed investigator site management activities in adherence to all applicable regulatory guidelines, maintaining appropriate document collection and validation.
14. Site Monitoring
- Conducted site monitoring visits performing source document verification, protocol review, regulatory compliance, drug accountability and ongoing site evaluation.
- Evaluated electronically updated clinical data via Medidata-Rave for study progress, generation of queries and preparation for site monitoring visits.
15. Regulatory Submissions
Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.
- Audited, collected, tabulated, and analyzed clinical data as required to support technical reports, publications and regulatory submissions.
- Contributed to the compilation, organization and production of protocols, clinical study reports, regulatory submissions, and controlled documentation.
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What skills help Clinical Research Associates find jobs?
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What skills stand out on clinical research associate resumes?
Professor, Department Chair, The University of Iowa
What clinical research associate skills would you recommend for someone trying to advance their career?
Ryan Barker
Visiting Instructor, State University of New York at Oswego
What technical skills for a clinical research associate 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 associates possess?
Assistant Director, Graduate Education & Career Connections, Morehouse School of Medicine
List of clinical research associate skills to add to your resume
The most important skills for a clinical research associate resume and required skills for a clinical research associate to have include:
- Patients
- Informed Consent
- CRA
- Clinical Trials
- Clinical Trial Management
- Oncology
- Data Collection
- IRB
- Ich
- GCP
- FDA
- Data Management
- Site Management
- Site Monitoring
- Regulatory Submissions
- Consent Forms
- Clinical Sites
- Study Sites
- CRF
- Clinical Practice
- Clinical Data
- Project Management
- Clinical Research Studies
- CRO
- ICH Guidelines
- IV
- Site Selection
- Data Entry
- Investigative Sites
- Study Start-Up
- Site Initiation
- Study Procedures
- Federal Regulations
- Trip Reports
- Excellent Interpersonal
- Query Resolution
- CTMS
- Excellent Computer
- Investigational Product
- Regulatory Compliance
- EDC
- Drug Accountability
- Data Queries
- Routine Monitoring
- TMF
- Field Training
- SAEs
- Study Initiation
- Site Compliance
Updated January 8, 2025