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clinical research associate: Resume Samples & Writing Guide
Employment history
Senior Clinical Research Associate, Columbia University New York City, New York
January 2016 – Present
- Assist in the preparation of informed consent documents
- Assist with the selection, initiation, and training of clinical sites
- Monitor clinical trial sites to ensure compliance with protocol and overall clinical objectives
Clinical Research Associate, Columbia University New York City, New York
July 2014 – December 2015
- Review clinical study protocols and related documents
- Participate in the development of clinical trial plans and strategies
- Maintain regulatory binders and files
Junior Clinical Research Associate, University of Washington Seattle, Washington
July 2013 – June 2014
- Develop and maintain positive relationships with clinical investigators and site staff
- Review and track case report forms for accuracy and completeness
- Review clinical study protocols and related documents
Education
University of Texas at Austin, Austin, Texas
Bachelor of Science in Regulatory Affairs, May, 2013
Skills
Planning
Professionalism
Critical Thinking
Time Management
Troubleshooting
Statistical Analysis
Study Management.
Data Analysis
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Professional Summary
An experienced Clinical Research Associate with expertise in clinical research and data management. Proven success in managing clinical studies from start to finish, and in developing and implementing research protocols.
Employment history
Lead Clinical Research Associate, National Institutes of Health Bethesda, Maryland
August 2013 – Present
- Assist with data entry and data management activities
- Maintain regulatory binders and files
- Participate in investigator meetings, teleconferences and site initiation visits
Associate Clinical Research Associate, Harvard University Cambridge, Massachusetts
August 2012 – July 2013
- Review and track case report forms for accuracy and completeness
- Assist with preparation of clinical study reports
- Assist with preparation of study-related materials
Jr. Clinical Research Associate, University of California Berkeley, California
March 2011 – July 2012
- Assist with preparation of study-related materials
- Assist with preparation of clinical study reports
- Review and track case report forms for accuracy and completeness
Education
University of Texas at Austin, Austin, Texas
Master of Science in Clinical Research Technology, January, 2011
University of Texas at Austin, Austin, Texas
Bachelor of Science in Clinical Research Monitoring, January, 2007
Skills
Emotional Intelligence
Public Speaking
Database Management
Presentation
Clinical Research
Scientific Writing
Clinical Trials
Troubleshooting
Employment history
Chief Clinical Research Associate, National Institutes of Health Bethesda, Maryland
June 2015 – Present
- Prepare, review and track regulatory documents
- Monitor clinical trial sites to ensure compliance with protocol and overall clinical objectives
- Assist with preparation of clinical study reports
Clinical Research Associate, Columbia University New York City, New York
November 2014 – May 2015
- Assist with the development of study budgets and contracts
- Assist with data entry and data management activities
- Review clinical study protocols and related documents
Jr. Clinical Research Associate, University of Washington Seattle, Washington
May 2014 – October 2014
- Prepare, review and track regulatory documents
- Monitor clinical trial sites to ensure compliance with protocol and overall clinical objectives
- Assist in the preparation of informed consent documents
Education
University of California, Berkeley, California
Doctor of Philosophy in Regulatory Affairs, March, 2014
University of California, Berkeley, California
Bachelor of Science in Clinical Research, March, 2010
Skills
Strategic Thinking
Communication
Customer Service
Adaptability
Database Management
GCP Guidelines
Scientific Writing
Data Validation
Employment history
Lead Clinical Research Associate, Johns Hopkins University Baltimore, Maryland
November 2016 – Present
- Assist with preparation of study-related materials
- Assist with preparation of clinical study reports
- Participate in investigator meetings, teleconferences and site initiation visits
Associate Clinical Research Associate, University of California Berkeley, California
May 2015 – October 2016
- Develop and maintain positive relationships with clinical investigators and site staff
- Monitor clinical trial sites to ensure compliance with protocol and overall clinical objectives
- Review and track case report forms for accuracy and completeness
Jr. Clinical Research Associate, University of Washington Seattle, Washington
June 2014 – May 2015
- Participate in the development of clinical trial plans and strategies
- Assist in the preparation of informed consent documents
- Participate in investigator meetings, teleconferences and site initiation visits
Education
University of Chicago, Chicago, Illinois
Bachelor of Science in Clinical Research Administration, April, 2014
Skills
Leadership
Attention to Detail
Networking
Written Communication
Protocol Development
Data Collection
Data Analysis
Regulatory Compliance
Employment history
Lead Clinical Research Associate, Johns Hopkins University Baltimore, Maryland
September 2019 – Present
- Participate in the development of clinical trial plans and strategies
- Develop and maintain positive relationships with clinical investigators and site staff
- Participate in investigator meetings, teleconferences and site initiation visits
Associate Clinical Research Associate, University of California Berkeley, California
September 2018 – August 2019
- Assist with preparation of study-related materials
- Assist in the preparation of informed consent documents
- Assist with preparation of clinical study reports
Jr. Clinical Research Associate, Johns Hopkins University Baltimore, Maryland
April 2017 – August 2018
- Participate in the development of clinical trial plans and strategies
- Assist with preparation of study-related materials
- Assist with preparation of clinical study reports
Education
Princeton University, Princeton, New Jersey
Regulatory Affairs Certificate, February, 2017
Skills
Stress Management
Data Analysis
Analytical
Project Management
Clinical Research
Data Analysis
Statistical Analysis
Risk Assessment
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clinical research associate Job Descriptions; Explained
If you're applying for an clinical research associate position, it's important to tailor your resume to the specific job requirements in order to differentiate yourself from other candidates. Including accurate and relevant information that directly aligns with the job description can greatly increase your chances of securing an interview with potential employers.
When crafting your resume, be sure to use action verbs and a clear, concise format to highlight your relevant skills and experience. Remember, the job description is your first opportunity to make an impression on recruiters, so pay close attention to the details and make sure you're presenting yourself in the best possible light.
1
clinical research associate
- Responsible for the detailed processes of recruitment, including consenting, application of medical device, and collection of data.
- Ensure integration of device with EEG, other respiratory, cardiac and additional biological data collected during in-patient period and to make data set available to research team.
- Enter data into relevant databases and prepare cohorts for in-house studies.
- Undertake statistical analysis of data.
- Maintain accurate and complete records and ensure data security and confidentiality of medical data.
- Ensure the highest standard of record keeping, maintaining
2
clinical research associate
- Conduct research to develop methodologies, instrumentation, and procedures for medical application, analyzing data and presenting findings to the scientific audience and general public.
- Write and publish articles in scientific journals.
- Consult with and advise physicians, educators, researchers, and others regarding medical applications of physics, biology, and chemistry.
- Teach principles of medicine and medical and laboratory procedures to physicians, residents, students, and technicians.
- Design research studies in collaboration with physicians, life scientists, or other professionals.
- Read current literature, attend meetings or conferences, and talk with colleagues to keep abreast of methodological or conceptual developments in fields such as biostatistics, pharmacology, life sciences, and social sciences.
- Collaborate with others in the organization to ensure successful implementation of chosen problem solutions.
3
clinical research associate (oncology)
- Ensured safe and right conduct of clinical trials according to ICH-GCP guidelines. Maintained understanding of PPD’s SOP (standard operating procedures) and also required PPD SOPs Provided clinical study progress reports to Clinical Trial Manager periodically.
- Planned & conducted pre-study site evaluation visits with Sr. Clinical Research Associates / Clinical Trial Monitor. Conducted clinical site feasibility and also help CTMs in study feasibility. Prepared and maintained Clinical Study Files including Trial master files (TMF), Investigator Site File (ISF), Investigator File (IF), study essential documents and regulatory documents.
- Prepared EC (Ethical committee) document for submission and other tools, templates and documents before clinical site initiation. Attended and assisted with IM (investigator meeting) in presentations, training materials, logistic preparation, and coordination.
- Planned & executed SIV (site initiation visit) with Sr. Clinical Research Associate/CTM. During site initiation visit (SIV) my responsibilities were meeting with clinical investigators (PI) and their teams to make sure that all aspects of the study were understood by the principal investigator and his/her staff, validated the suitability of the EC/IRB & to ensure that all records required for the study were completed.
- Managed the clinical central laboratory in regard to issues of site. Planned, conducted site monitoring visits (SMV) as per study protocol under the supervision of the CTM/Designee. Closely kept track of patient recruitment procedure by contacting clinical sites & verify patient screening & enrollment development. Assessed the subjects (patients) for study protocol compliance though SDV (source data verification). Monitored patient Informed Consent progression for clinical study. Examined on-site CRFs (Case Report Forms) aligned with source documents for data authentication.
- Identified discrepancies in the case report forms against the source documents occasionally, resolved them and after that took away the CRFs. Followed up with clinical site for resolution of DCFs or any queries. Ensured that adverse event/serious adverse event AE/SAE were reported and followed up with the concern departments.
- Assessed appropriate Investigational Product (IP) answerability at site. Planned and conducted site close out visits (SCV) and made sure that collection of all clinical study data was completed. Prepared the applicable site visit reports and follow up letters. Subsequent to study completion, ensured that investigational products (IP) of the study were returned to the PPD.
4
clinical research associate
- Participating in the site selection process, feasibility assessment;
- Performing all types of study site monitoring visits;
- CRF review and source data verification;
- Preparation for study submission to the regulatory authorities;
- Site management; visit reporting;
- S/AE processing, reporting and follow-up;
- Ensuring on-site compliance with national regulations, GCP, protocol and procedures;
5
sr. clinical research associate
- Conducting pre-study, initiation, monitoring, and close-out visits according to SOPs and GCP;
- Site management for assigned sites including written and verbal communication and scheduling of monitoring visits;
- Preparation of visit reports and maintenance of study-related databases;
- Taking over Lead CRA responsibilities on a project, acting as the primary contact for all monitoring- related questions for the monitoring team;
- Facilitating training for new CRAs.
clinical research associate Job Skills
For an clinical research associate position, your job skills are a key factor in demonstrating your value to the company and showing recruiters that you're the ight fit for the role. It's important to be specific when highlighting your skills and ensure that they are directly aligned with the job requirements, as this can greatly improve your chances of being hired. By showcasing your relevant skills and experience, you can make a compelling case for why you're the best candidate for the job.
How to include technical skills in your resume:
Technical skills are a set of specialized abilities and knowledge required to perform a particular job
effectively. Some examples of technical skills are data analysis, project management, software proficiency,
and programming languages, to name a few.
Add the technical skills that will get hired in your career
field with our simple-to-use resume builder. Select your desired resume template, once you reach the skills
section of the builder, manually write in the skill or simply click on "Add more skills". This will
automatically generate the best skills for your career field, choose your skill level, and hit "Save &
Next."
- Data Analysis
- Quality Assurance
- Troubleshooting
- Database Management
- Clinical Research
- Regulatory Compliance
- Statistical Analysis
- Clinical Trials
- Protocol Development
- Project Management
- Risk Assessment
- Laboratory Techniques
- Data Collection
- Scientific Writing
- GCP Guidelines
- Electronic Data Capture
- Data Validation
- Medical Terminology
- Good Documentation Practices
- Study Management.
How to include soft skills in your resume:
Soft skills are non-technical skills that relate to how you work and that can be used in any job. Including
soft skills such as time management, creative thinking, teamwork, and conflict resolution demonstrate your
problem-solving abilities and show that you navigate challenges and changes in the workplace
efficiently.
Add competitive soft skills to make your resume stand-out to recruiters! Simply select
your preferred resume template in the skills section, enter the skills manually or use the "Add more skills"
option. Our resume builder will generate the most relevant soft skills for your career path. Choose your
proficiency level for each skill, and then click "Save & Next" to proceed to the next section.
- Communication
- Interpersonal
- Leadership
- Time Management
- Problem Solving
- Decision Making
- Critical Thinking
- Creativity
- Adaptability
- Teamwork
- Organization
- Planning
- Public Speaking
- Negotiation
- Conflict Resolution
- Research
- Analytical
- Attention to Detail
- Self-Motivation
- Stress Management
- Collaboration
- Coaching
- Mentoring
- Listening
- Networking
- Strategic Thinking
- Negotiation
- Emotional Intelligence
- Adaptability
- Flexibility
- Reliability
- Professionalism
- Computer Literacy
- Technical
- Data Analysis
- Project Management
- Customer Service
- Presentation
- Written Communication
- Social Media
- Troubleshooting
- Quality Assurance
- Collaboration
- Supervisory
- Risk Management
- Database Management
- Training
- Innovation
- Documentation
- Accounting
- Financial Management
- Visualization
- Reporting
- Business Acumen
- Process Improvement
- Documentation
- Relationship Management.
How to Improve Your clinical research associate Resume
Navigating resume pitfalls can mean the difference between landing an interview or not. Missing job descriptions or unexplained work history gaps can cause recruiters to hesitate. Let's not even talk about the impact of bad grammar, and forgetting your contact info could leave your potential employer hanging. Aim to be comprehensive, concise, and accurate.
Employment history
Lead Clinical Research Associate, University of Texas at Austin Austin, Texas
May 2016 – May 2022
- Participate in the development of clinical trial plans and strategies
- Assist with data entry and data management activities
- Review clinical study protocols and related documents
Clinical Research Associate, Harvard University Cambridge, Massachusetts
November 2015 – April 2016
- Participate in the development of clinical trial plans and strategies
- Assist with the development of study-related materials, such as training materials and manuals
- Assist with the development of study budgets and contracts
Entry Level Clinical Research Associate, University of California Berkeley, California
May 2014 – October 2015
Education
University of Texas at Austin, Austin, Texas
Bachelor of Science in Biostatistics, March, 2014
Skills
Attention to Detail
Negotiation
Interpersonal
Listening
Quality Assurance
Scientific Writing
Data Validation
Good Documentation Practices
Unexplained Year Gaps and Missing Job Experiences are a No-no
Gaps in your resume can prevent recruiters from hiring you if you don't explain them.
Key Insights- It's okay to have gaps in your work experience but always offer a valid explanation instead of just hiding it.
- Use the gap to talk about positive attributes or additional skills you've learned.
- Be honest and straightforward about the gap and explain it using a professional summary.
How to Optimize Your clinical research associate Resume
Keep an eye out for these resume traps. Neglecting to detail your job roles or explain gaps in your career can lead to unnecessary doubts. Grammar blunders can reflect negatively on you, and without contact information, how can employers reach you? Be meticulous and complete.
Andrew Hawkins 301 Maplewood Drive, Socorro, NM 87801
Employment history
Lead Clinical Research Associate, University of Washington Seattle, Washington
March 2019 – Present
- Develp & maintain positve relationships with clinical investigaters & site staff
- Assit with the develpment of study-related materials, such as training materials & manuels
- Review clinical study protocols & related documnets.
Associate Clinical Research Associate, University of Michigan Ann Arbor, Michigan
March 2018 – February 2019
- Assist in the preperation of informed consent documents
- Prepare, reviw and track regulatory documents
- Review and track case report forms for accuracey and completness
Entry Level Clinical Research Associate, National Institutes of Health Bethesda, Maryland
August 2017 – February 2018
- Assist with the selection, initiation, and trainning of clinical sites
- Maintain regulatory binders and files
- Review and track case report forms for accurracy and completeness.
Education
University of Michigan, Ann Arbor, Michigan
Biostatistics Certificate, July, 2017
Skills
Business Acumen
Financial Management
Critical Thinking
Adaptability
Laboratory Techniques
Good Documentation Practices
GCP Guidelines
Statistical Analysis
Avoid Spelling Mistakes and Include your Contact Information
Missing contact information prevents recruiters from understanding you're the best fit for the position.
Key Insights- Make sure you're not missing contact information on your resume. That should include your full name, telephone number and email address.
- Make sure to use a professional email address as part of your contact information.
- Highlight your contact information and double check that everything is accurate to help recruiters get in touch with you.
clinical research associate Cover Letter Example
A cover letter can be a valuable addition to your job application when applying for an clinical research associate position. Cover letters provide a concise summary of your qualifications, skills, and experience, also it also gives you an opportunity to explain why you're the best fit for the job. Crafting a cover letter that showcases your relevant experience and enthusiasm for the Accounts Payable role can significantly improve your chances of securing an interview.
Chief Clinical Research Associate
University of California
Berkeley, California
University of California
Berkeley, California
Esteemed University of California Hiring Team
I am writing to express my interest in the Chief Clinical Research Associate role at University of California. As a Clinical Research Associate with 10 years of experience, I am confident that I possess the necessary skills and qualifications to excel in this position.
My life experiences have taught me the importance of hard work, dedication, and collaboration. Whether it was on the work, or just personally, I have always been committed to pursuing my goals with passion and tenacity. I am confident that throughout all of these years I have gained the skills and expertise necessary to succeed in this role and be a great asset for University of California. I am eager to join a team that shares my values and work towards a common goal.
Thank you for considering my application for the Chief Clinical Research Associate role. I am very passionate about this field and possess a deep understanding of the industry so, I am thrilled about the opportunity to contribute to your organization's success.
Bests,
Ollie Davis
855-434-0873
[email protected]
Ollie Davis
Showcase your most significant accomplishments and qualifications with this cover
letter.
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Build your Resume in 15 minutes
Give yourself the best chance of standing out from the
competition!
Create an awesome resume that meets the expectations of potential employers with our selection of professional, field-tested resume templates.
Create an awesome resume that meets the expectations of potential employers with our selection of professional, field-tested resume templates.