CLINICAL RESEARCH ASSOCIATE SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Dec 22, 2024 -The Clinical Research Associate has a solid background in clinical monitoring and laboratory work within the in vitro diagnostic and medical device industries. This role requires proficiency in Microsoft Word, Excel, and Access, and knowledge of ICH/GCP and FDA regulations, demonstrating strong organizational, analytical, and problem-solving skills. This individual is also adept at site monitoring and logistical execution of clinical trials, with excellent interpersonal and communication abilities.

Essential Hard and Soft Skills for a Standout Clinical Research Associate Resume
  • Clinical Trial Monitoring
  • Data Management
  • Regulatory Compliance
  • Good Clinical Practice
  • Protocol Development
  • Adverse Event Reporting
  • Electronic Data Capture
  • Statistical Analysis
  • Laboratory Techniques
  • Project Management
  • Attention to Detail
  • Problem Solving
  • Communication Skills
  • Time Management
  • Teamwork
  • Adaptability
  • Critical Thinking
  • Conflict Resolution
  • Interpersonal Skills
  • Leadership

Summary of Clinical Research Associate Knowledge and Qualifications on Resume

1. BS in Biology with 4 years of experience

  • Tertiary qualifications in a related science or health care discipline.
  • Experience in clinical trial monitoring within a clinical research organization or pharmaceutical company.
  • Excellent working knowledge of ICH-GCP, ethical and regulatory requirements.
  • Excellent social skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders.
  • Excellent organisational skills and ability to organise, take initiative and follow-up independently.
  • Excellent interpersonal skills to relate easily and effectively with people within and outside the University, including both strong written and verbal communications.
  • Strong ability to multi-task, prioritize and follow up.
  • Skill to use a personal computer, computer software programs at the level of sophistication required for general office work.
  • Knowledge of Outlook, Word, Excel, and PowerPoint.
  • Familiarity with the Internet and how to conduct searches.
  • Proficient writing skills to prepare/compose/review a variety of materials with accuracy and completeness.
  • Familiarity with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to ensure confidentiality, privacy, and security of patient information.

2. BA in Chemistry with 5 years of experience

  • Experience in clinical study coordination, clinical site monitoring or clinical study management
  • Prior experience with current Good Clinical Practices (cGCP) and Code of Federal Regulations (CFR) 
  • A background in biomedical/healthcare services with laboratory experience
  • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint).
  • Excellent writing and verbal communication skills and well-organized and detail-oriented.
  • Impeccable record-keeping and filing skills.
  • Excellent time management skills and ability to give presentations and teach others.
  • Ability to work effectively in a team, and also work independently on assigned tasks
  • Have research and/or pediatric RN experience
  • Certified Clinical Research Professional (CCRP) (Certification)
  • Demonstrated communication (written and oral), problem-solving, leadership, and collaborative skills.
  • Demonstrated computer word processing skills.

3. BS in Nursing with 3 years of experience

  • Experience with Phase I-II trials and have ACRP/SOCRA certification or other Clinical Research Certification
  • Thorough knowledge and understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance
  • Proficiency in Microsoft Word, Internet, Excel, and e-mail 
  • Work well with others and possess excellent communication skills and problem-solving abilities.
  • Highly organized and attentive to details.
  • Communicates well with patients, sponsors and staff on interpersonal and technical levels, both verbally and in writing
  • Demonstrates high integrity and maintains confidentiality of all information.
  • Interact favorably with people by phone and in person, and work effectively as part of a team.
  • Perform detailed, accurate computer entry functions.
  • Good data entry skills and highly motivated and able to take initiative.
  • Able to manage multiple research projects within a fast-paced environment, able to collect and manage large amounts of data and maintain databases
  • Ability to communicate progress, challenges and results effectively.

4. BS in Pharmacology with 6 years of experience

  • Involved in ongoing quality review of documents generated for completeness and accuracy.
  • Report to work as scheduled and display a professional attitude.
  • Oncology experience and experience with Electronic Data Capture systems
  • Coursework in research or applied research methods
  • Certification with the Association of Clinical Research Professionals (ACRP) or CRPC (Clinical Research Professional Certification) with the Society of Clinical Research Association (SOCRA) or obtained within one year of eligible hours worked as defined by ACRP or SOCRA.
  • Experience in Physician Office Practice and Clinical research experience.
  • Proficiency with MS Office Products (Word, Excel, PowerPoint, SharePoint) and other electronic systems (e.g., Veeva eTMF) and databases (e.g., Medidata RAVE EDC). Experience with Zoom, Smartsheet and Spotfire is helpful
  • Ability to travel on occasion for oversight visits, meetings, or training (minimal travel)
  • Adhere to the highest degree of professional standards and strict confidentiality on matters that require discretion
  • Working knowledge of drug development, CFR, ICH/GCP guidelines and applicable regulatory requirements
  • Excellent communication, organizational, and analytical skills
  • Ability to work effectively in a high-paced, fast-changing environment

5. BA in Biochemistry with 4 years of experience

  • An equivalent combination of education and qualifying experience
  • Clinical operations experience in the pharmaceutical industry or a related sector. 
  • Prior experience as a Clinical Research Associate 
  • Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team
  • Flexibility to perform a broad range of trial-based responsibilities
  • CRA experience, practical experience in pre-study, initiation, monitoring and closeout visit according to global standards
  • Experience with handling eCRF, eTMF and CTMS systems
  • Experience in a medical environment (e.g. nursing)
  • Knowledge of applicable standards and regulations for clinical trials
  • Good level of English and experience in a CRA and/or study coordinator positions
  • Strong communication and negotiation skills
  • Ability to prioritize and handle multiple tasks

6. BS in Biotechnology with 5 years of experience

  • Effective planning and organizational skills with a result-oriented approach
  • Analytical thinking, critical reasoning ability, good command of MS Office applications
  • Excellent skills in basic computer applications (Word, Excel, Access, PowerPoint)
  • Excellent writing and verbal communication skills in German AND English.
  • Basic technical understanding and willingness to work hands-on in a laboratory with infectious material.
  • Extensive experience performing source data verification in an electronic data capture environment
  • Trial monitoring experience either regional or site monitoring of Phase III clinical trials
  • Site/Trial management experience, hepatology-NASH experience
  • Experience with paper and electronic document management systems (eTMF, CTMS, etc.).
  • Experience working in a global environment
  • Extensive experience collaborating/interacting with counterparts at sponsors and other CROs/vendors (laboratories, drug depots, etc.)

7. BA in Public Health with 2 years of experience

  • Experience with In Vitro Diagnostic (IVD) products.
  • Experience in monitoring sites, excellent team skills, ability to prioritize and multi-task in a fast-paced environment.
  • Proficient in Microsoft Office Applications, such as Word, Excel, Access, PowerPoint etc.
  • Experience in the handling and shipping of Biohazardous specimens.
  • Must remain current with regulatory and clinical requirements for diagnostic products and translate the regulatory requirements into clinical trials.
  • Knowledge of GCP & ICH guidelines and FDA regulations.
  • Familiar with clinical literature in the field of study and related areas.
  • Experience managing serious adverse events in collaboration with safety surveillance. 
  • Ability to ensure events are being properly followed to completion
  • Excellent communication skills written and verbal
  • Must be able to work independently under minimal supervision
  • Good understanding of Clinical Study Management including monitoring, study drug handling and data management.

8. BS in Biomedical Science with 3 years of experience

  • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
  • Good knowledge of relevant local regulations.
  • Good medical knowledge and ability to learn relevant Therapeutic Areas.
  • Basic understanding of the drug development process.
  • Monitoring experience or combination of on-site monitoring and clinical research experience or education
  • CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites.
  • Demonstrated successful performance in CRA I competencies
  • Have oncology CRA experience at a contract research organization (CRO) or sponsor company monitoring clinical trials at investigative sites.
  • Early Phase Oncology Experience
  • Experience conducting all visit types (PSV, SIV, RMV, and COV)
  • Experience as a clinical research associate within a medical device/pharmaceutical/biotechnology company

9. BA in Health Sciences with 5 years of experience

  • Experience in clinical research/clinical monitoring or equivalent combination of education and experience.
  • Laboratory experience and previous experience with in vitro diagnostic or medical device industry or clinical lab
  • Must be detail oriented and have excellent interpersonal, organizational, and communication skills (speaking, listening, writing).
  • Must be proficient in MS Word, Excel and Access.
  • Knowledge of ICH / GCP and FDA regulations
  • Expertise of site monitoring and logistical execution of clinical trials
  • Experience within a pharmaceutical company and/or CRO
  • Demonstrated computer skills (Microsoft Excel, Word, Outlook, and PowerPoint)
  • GCP course and fluent in Hebrew, and have good English skills
  • Good communication skills and have a teamwork spirit
  • Good analytical and problem-solving skills: seeing change as an opportunity to improve performance and contribute to the business
  • Strong teamwork and communication skills
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