CLINICAL RESEARCH SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Published: May 22, 2025 – The Clinical Research Professional has experience in conducting clinical trials across various phases, ensuring strict adherence to regulatory guidelines and Good Clinical Practice (GCP). This role requires skills in data collection, monitoring, and documentation to support accurate reporting and compliance. The position is also adept at collaborating with cross-functional teams to facilitate patient recruitment, protocol implementation, and study coordination.

Essential Hard and Soft Skills for a Standout Clinical Research Resume
  • Regulatory Compliance
  • Database Management
  • ICF Creation
  • IRB Coordination
  • Data Entry
  • Trial Monitoring
  • Report Writing
  • Protocol Development
  • Data Analysis
  • Project Management
  • Patient Communication
  • Team Collaboration
  • Issue Resolution
  • Staff Coordination
  • Site Liaison
  • Project Representation
  • Stakeholder Collaboration
  • Patient Coordination
  • Violation Troubleshooting
  • Relationship Building

Summary of Clinical Research Knowledge and Qualifications on Resume

1. BS in Health Sciences with 2 years of Experience

  • Strong organizational, critical thinking, and problem-solving skills.
  • Excellent demonstrated interpersonal, verbal, and written communication skills.
  • Strong technological proficiency in multiple platforms, including Microsoft, Google, and web-based computer applications.
  • Prior clinical operations experience
  • Medical terminology exposure, such as a medical scribe, medical assistant, or volunteer.
  • Prior volunteer or employed role within a research setting.
  • Prior experience navigating patient scheduling platforms and/or an electronic medical record system.

2. BS in Clinical Research with 4 years of Experience

  • Previous medical office experience
  • Must have exceptional organizational and analytical skills. 
  • Self-motivated and able to work independently as well as in a team-oriented setting with attention to detail
  • Able to meet multiple deadlines for concurrent projects. 
  • Must be proficient in Excel. 
  • Must provide own transportation to clinics, hospitals, and associated agencies
  • Manual dexterity, prolonged standing, or sitting. 
  • Able to lift light to medium-weight objects, which may be bulky and awkward. 
  • Ability to travel to developmental, educational, and promotional activities. 
  • Physical and mental stamina to function effectively in an environment with multiple fluctuating priorities. 
  • Ability to communicate effectively with individuals of all cultures and levels of authority. 
  • Exposure to hazardous materials (study agents, biohazards, pathology specimens).

3. BS in Microbiology with 5 years of Experience

  • Trial monitoring experience, either regional or site monitoring of Phase III clinical trials
  • Site/Trial management experience
  • Hepatology-NASH working experience
  • Extensive experience collaborating/interacting with counterparts at sponsors and other CROs/vendors (laboratories, drug depots, etc.)
  • Must be commutable to a major airport, travel up to 50%
  • Experience managing serious adverse events in collaboration with safety surveillance. 
  • Ensuring events are being properly followed to completion
  • Extensive experience performing source data verification in an electronic data capture environment
  • Experience with paper and electronic document management systems (eTMF, CTMS, etc.).
  • Experience working in a global environment
  • Excellent communication skills, written and verbal, and must be able to work independently under minimal supervision

4. BS in Clinical Research with 4 years of Experience

  • Experience with Procurement Operations and eProcurement.
  • Business process knowledge of supplier enablement, Finance, and Compliance risk
  • Experience with ERP and S2P technology/platforms, and experience with the Coupa IT platform
  • The ability to multitask and problem-solve.
  • Experience with the process, quality control, and workflow management
  • Strong teamwork and collaboration skills to work effectively with stakeholders across the company.
  • Strong verbal and written communication skills
  • Proficiency in Microsoft Suite (Word, Excel, and PowerPoint).
  • Strong attention to detail and the ability to organize data.
  • Ability to adapt to new technology/platforms.
  • An inquisitive nature to help identify process improvements.

5. BS in Health Information Management with 3 years of Experience

  • Clinical trial regulatory experience.
  • Knowledge of standard qualitative and quantitative data collection techniques.
  • Must have human subjects training.
  • Familiarity with social science research methodology.
  • Prior experience within the DoD/VA systems of care
  • Hold an ACRP and/or CCRP and/or Specialty Healthcare License
  • The ability to follow detailed instructions.
  • Excellent communication and organizational skills 
  • Have a basic clinical acumen
  • Knowledge of universal precautions and proficiency in conducting research.

6. BS in Genetics with 5 years of Experience

  • Excellent organization and oral/written communications skills
  • Strong interpersonal skills and the ability to effectively interact with all levels of staff and external contacts.
  • Must have strong analytical skills and conceptual thinking.
  • Must have the ability to supervise others, with detail-oriented, and have the ability to follow through.
  • Possess the ability to work independently and display initiative to introduce innovations to the research study.
  • Ability to effectively manage time and prioritize workload, as well as prioritize tasks and set deadlines.
  • Must practice discretion and adhere to hospital confidentiality guidelines at all times.
  • The ability to prepare and monitor budgets.
  • Work independently with very little guidance from supervisors.
  • Ability to resolve technical problems and interpret the acceptability of data results.
  • Keen knowledge of data management programs.
  • Ability to identify problems and develop sound solutions.

7. BS in Statistics with 6 years of Experience

  • Research experience, clinical research experience
  • Experience working with IRB application procedures, progress reports, and budgets.
  • Supervisory working experience
  • Excellent organizational and managerial skills. 
  • Analytical ability to develop and institute program goals and systems. 
  • Interpersonal skills to provide strong leadership to assigned staff, and deal effectively with medical staff, community agencies and site staff.
  • Maintains awareness of the requirements of accrediting and regulatory agencies and monitors compliance.
  • Computer-based skills to develop and maintain databases, information systems and manage study data.
  • Strong contributor and strong commitment to quality, organizational and time management skills.
  • Ability to demonstrate professionalism and respect for the subject's rights.
  • Able to make independent and effective decisions in appropriate situations.

8. BS in Medical Laboratory Science with 11 years of Experience

  • Clinical research experience and a strong knowledge of drug development, or equivalent
  • Technical operational experience in early phases of clinical trial planning, start-up, conduct, reporting and publishing
  • Experience in clinical oncology, with recent immuno-oncology experience
  • Extensive direct knowledge of the clinical development process, with the ability to understand concepts of various phases and principles of study design
  • Experience with interacting with medical monitors, development operations, and clinical investigators
  • A thorough understanding of ICH, GCP, and relevant regulatory requirements
  • A thorough understanding of clinical research methodology, including study design, protocol writing, and CRF preparation, as well as a knowledge of GCP and local regulatory requirements
  • Working knowledge of the IND/NDA process acquired through direct industrial experience
  • Knowledge of medical, scientific, and clinical research techniques in the assigned therapeutic area.
  • The ability to work with cross-functional teams in a matrix environment
  • Strong organizational and time management skills with meticulous and detail-oriented
  • Self-motivated and able to work with limited supervision
  • Excellent interpersonal and communication skills
  • Proficiency with Microsoft Outlook, Excel, Word, PowerPoint, and Office Timeline/Project.

9. BS in Biomedical Science with 8 years of Experience

  • Registration with no limitations to practice within the Nursing and Midwifery Council (Adult)
  • Clinical research working experience
  • A team player with well-developed interpersonal and communication skills
  • A patient-focused attitude
  • Previous experience that provides the knowledge, skills, and abilities to perform the job
  • Excellent understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.)
  • Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive, complex information, and problem solving
  • Excellent decision-making, negotiation, and influencing skills
  • Excellent communication skills and English fluency
  • Excellent organizational skills
  • Essential proficiency in basic computer applications
  • Excellent interpersonal skills to work in a team environment

10. BS in Microbiology with 5 years of Experience

  • Experience with the current state nursing licensure
  • Professional knowledge of the principles, theories, techniques, and practices of nursing with immunologic illnesses
  • Experience in a clinical research environment
  • Knowledge of clinical research data collection and clinical data report preparation
  • Working knowledge of ICH GCPs
  • Prior experience in adult and pediatric clinical trials management
  • Must be CPR certified or certifiable
  • Knowledge of Microsoft Office Suite (MS Word, Excel, Outlook) and spreadsheet applications
  • Strong communications skills, both oral and written
  • Excellent analytical, organizational, and time management skills
  • Ability to participate in efforts to ensure scientific quality and human subjects’ protection
  • Ability to oversee ongoing protocol operations to ensure study compliance and troubleshoot possible protocol violations

11. BS in Chemistry with 6 years of Experience

  • Experience in clinical research and development.
  • Clinical drug development process experience
  • Knowledge of and strict adherence to GCP/ICH guidelines and internal SOPs in Clinical Research and Development.
  • Excellent managerial and leadership skills or clear potential to develop such skills.
  • Excellent verbal communication skills to effectively represent at a corporate level, with internal working groups/project teams and external academic/industrial/regulatory organizations.
  • Excellent technical writing skills.
  • Team player, possesses a sense of urgency, is mentorable, and exhibits potential for mentoring others.
  • Must have planning skills to schedule activities to meet Clinical Research and Development and project team deadlines. 
  • Problem-solving ability, and skills to address medical, clinical study, and technical questions in a multi-disciplinary environment
  • Must be technically proficient with standard PC software (Word, Excel, PowerPoint, and Desktop products like Outlook).
  • Must keep abreast of medical and scientific literature within the relevant therapeutic area in which the individual is working. 
  • Must maintain high ethical standards and integrity at all times.

12. BS in Epidemiology with 8 years of Experience

  • Experience in product and clinical development with demonstrated expertise in trial design, endpoints, and operations in a Biotech or Pharmaceutical company
  • Understanding of GCP, ICH, and regional/local regulations
  • Experience in both early and late phase development
  • Medical knowledge and experience in clinical development/ operations (preferably CNS and/or rare disease)
  • Experience reviewing clinical data outputs
  • Ability to perform literature searches and to utilize library services
  • Ability to conduct basic data analyses using Excel and other tools
  • Basic understanding of biostatistics to allow effective interaction with a biostatistics expert
  • Excellent verbal and written communication skills
  • Team player, able to work cross-functionally
  • Strong problem-solving and resolution skills
  • Ability to drive decision-making within a multi-disciplinary, multi-regional matrix team

13. BS in Biology with 10 years of Experience

  • Direct biotechnology or pharmaceutical industry experience in clinical research and/or Medical Affairs.
  • Prior industry experience as a clinical scientist or medical writer
  • Experience with the preparation of clinical protocols, study reports, IND, IB, NDA/CTD documents, or peer-reviewed publications
  • Experience in multiple therapeutic areas, with prior experience in Hepatology, Gastrointestinal, Endocrinology, or related field
  • Familiarity with GCPs, ICH guidelines, and FDA/EMA/CHMP regulations.
  • Demonstrated ability to author or oversee regulatory documents (e.g., protocols, CSRs, briefing packages).
  • Strong interpersonal and communication skills with a proactive approach.
  • Expertise in navigating scientific literature, interpretation of data, and display of data.
  • Demonstrated problem-solving skills (including taking ownership to ensure timely resolution)
  • A strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
  • Able to work both independently and in a team environment.
  • Detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously.
  • Highly proficient in MS Office Suite (Word, Excel, and PowerPoint).
  • Ability to travel, in some cases, internationally.

14. BS in Clinical Research with 4 years of Experience

  • Relevant experience in clinical research, hospital, engineering, or medical devices
  • Experience in the healthcare industry or management of clinical devices
  • Experience in a cath lab, biomedical engineering, hospital/clinic, or prior medical sales
  • Ability to work with many different customers from varying backgrounds
  • Experience collaborating with cross-functional clinical partners, customers, or sales colleagues in the health care industry.
  • Knowledge in Pre-market, post-market, and product surveillance
  • Investigator Initiated Trial, Sponsor Initiated Trial
  • Overall study and/or site management experience in different phases of the study
  • Ability to travel ≥25% of the time

15. BS in Biochemistry with 3 years of Experience

  • Previous clinical research or related technical experience
  • Experience with medical devices
  • Certification from a recognized professional organization (i.e., CCRA, RAC, CDE)
  • Knowledge of the application of scientific research principles
  • Understanding of Good Clinical Practices
  • Demonstrated competencies in leadership in a professional and ethical manner
  • Sexcellent presentation skills and influencing others
  • Strong English written and oral communication skills
  • Must have solid technical writing
  • Have strong project management skills
Relevant Information
Clinical Research Manager Skills, Experience, and Job Requirements
Clinical Research Specialist Skills, Experience, and Job Requirements
Clinical Research Assistant Skills, Experience, and Job Requirements
Clinical Research Associate Skills, Experience, and Job Requirements