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Senior Clinical Research Associate skills for your resume and career

15 senior clinical research associate skills for your resume and career
1. Patients
- Verified informed consent procedures and protocol requirements based on applicable regulatory requirements to ensure protection of study patients.
- Performed Quantitative sensory testing on chronic pain patients in accordance with complex research protocol.
2. Informed Consent
- Managed the financial approval process for Clinical Site Agreements, Informed Consent Customization Site Regulatory Package, and IRB/IEC application preparation/submission.
- Participated in protocol development, generation of standard informed consent and other related study documents and forms.
3. 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.
- Provided site management for both therapeutic and supportive care oncology protocols that were complex and required knowledge in advanced therapeutic areas.
- Developed dose calculator to help monitors determine proper dosing of subjects in oncology study.
4. 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.
- Attended Investigator meetings and presented CRA responsibilities to audience.
- Participated in CRA protocol specific training and development.
5. 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.
- Created and maintained documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports.
- Reviewed and tracked essential regulatory documents and consistently prepared high quality reports of site management and monitoring activities.
6. Field Training
- Acted as a mentor to new associates for purposes of field training.
- Conducted field training and mentoring of junior staff members.
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- Maintained clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor.
- Provided information for input into Clinical Trial Management System, and updated information as necessary.
8. Clinical Trials
- Designed, conducted and analyzed the results of a clinical trial for an image-guided surgical navigation system for neurosurgery.
- Assist in formulating and implementing guidelines and processes in establishing independent safety monitoring boards and committees for clinical trials.
9. Site Monitoring
- Provided reports of these clinical site monitoring visits and reviewed/collected critical documents.
- Complete clinical site monitoring according to established guidelines.
10. 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.
- Develop and execute clinical research operations in order to provide accurate data collection and assure GCP guidelines are followed.
- Monitored activities at clinical sites to ensure accurate data collection as well as regulatory adherence.
11. 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.
- Participated in clinical training programs and maintained awareness of developments in the field of clinical research and data management as needed.
- Coordinated setting up electronic data capture with data management and outside vendor for a complicated post-operative pain study.
12. 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.
- Coordinated and trained the staff for the internal audit of clinical trial documents transferred from the CRO to the sponsor site.
- Coordinated all key communications externally (CRO, Investigator, site study staff) and internal (study team).
13. Clinical Sites
- Maintain close communication with clinical sites to assure adherence to protocol and regulatory guidelines, maximize study enrollment and resolve problems.
- Identify and select investigators and clinical sites, and utilize risk-based monitoring while performing on-site or remote visits.
14. 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.
- Interacted on a daily basis with Principal and Co-Investigators regarding protocol revisions, additions, and any pertinent IRB recommendations.
- Assisted site with development of essential study documents and IRB submission/approvals.
15. Clinical Data
- Presented informal and formal clinical data presentations to Abbott assay project teams and external clinical investigators.
- Participated in clinical data analysis, summary and reporting for regulatory and for marketing purposes.
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What skills help Senior Clinical Research Associates find jobs?
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What technical skills for a Senior 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 Senior Clinical Research Associates possess?
Research Professor Financial Engineering, Director Hanlon Laboratories, Director Financial Analytics program, Stevens Institute of Technology
List of senior clinical research associate skills to add to your resume
The most important skills for a senior clinical research associate resume and required skills for a senior clinical research associate to have include:
- Patients
- Informed Consent
- Oncology
- CRA
- Site Management
- Field Training
- Clinical Trial Management
- Clinical Trials
- Site Monitoring
- Data Collection
- Data Management
- CRO
- Clinical Sites
- IRB
- Clinical Data
- IV
- CRF
- ICH Guidelines
- Clinical Practice
- EDC
- CTMS
- Study Procedures
- Trip Reports
- Investigational Product
- Ich
- GCP
- Routine Monitoring
- Pre-study
- Query Resolution
- FDA
- Clinical Studies
- Site Selection
- SAEs
- Consent Forms
- Site Initiation
- Regulatory Submissions
- Investigative Sites
- TMF
- Site Issues
- Federal Regulations
- Corrective Action
- Team Training
- CNS
- Phase II
- Phase III
- Regulatory Compliance
- Expense Reports
Updated January 8, 2025