Role Description

Scientific > Clinical Research Scientist

Salary National Average

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92898.0000 114588.0000 154280.0000

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Short Description:

A Clinical Research Scientist designs, conducts, and analyzes clinical trials to evaluate the safety and effectiveness of new drugs, treatments, and medical devices. They work closely with healthcare professionals, regulatory bodies, and pharmaceutical companies to ensure clinical studies comply with ethical and regulatory standards. This role involves collecting and interpreting data, preparing reports, and contributing to medical advancements through evidence-based research.

Duties / Responsibilities:

  • Develop and design clinical research protocols to test new treatments or medical devices.
  • Collaborate with healthcare professionals to determine study objectives and methodologies.
  • Oversee the planning and execution of clinical trials, ensuring adherence to protocols.
  • Coordinate with trial sites, investigators, and participants.
  • Ensure accurate and thorough collection of clinical trial data.
  • Maintain databases and ensure data integrity throughout the study.
  • Monitor the safety and well-being of trial participants.
  • Identify and report any adverse effects or complications.
  • Ensure clinical trials comply with regulatory requirements, including FDA or EMA guidelines.
  • Obtain necessary approvals from ethics committees and institutional review boards (IRBs).
  • Analyze clinical trial data using statistical methods and software.
  • Interpret results to determine the efficacy and safety of the treatments or devices being tested.
  • Prepare detailed reports, study results, and research publications for stakeholders.
  • Document findings for submission to regulatory agencies and scientific journals.
  • Work with multidisciplinary teams, including clinicians, regulatory professionals, and statisticians.
  • Participate in meetings and discussions regarding trial progress and results.
  • Modify and update study protocols as necessary to address unexpected challenges or new insights.
  • Train trial investigators and clinical staff on study protocols and procedures.

Skills / Requirements / Qualifications

 

  • Educational Background: PhD in life sciences, pharmacology, biochemistry, or related field. Master's degree with relevant experience may be considered in some cases.
  • Experience: Experience in clinical research or related fields, including trial design and data analysis. Familiarity with Good Clinical Practice (GCP) guidelines and regulatory processes.
  • Technical Skills: Proficiency in statistical software (e.g., SAS, SPSS) and data management tools. Strong understanding of medical terminology and clinical trial phases.
  • Analytical Skills: Strong analytical abilities to interpret complex data and draw valid conclusions. Ability to troubleshoot issues and adapt protocols as needed.
  • Communication Skills: Excellent written and verbal communication skills for preparing reports and presentations. Ability to communicate complex scientific findings to both technical and non-technical audiences.
  • Attention to Detail: High degree of accuracy in data collection, analysis, and reporting. Strong focus on maintaining data integrity and compliance with ethical standards.
  • Problem-Solving Skills: Ability to identify challenges during clinical trials and implement solutions. Strong decision-making skills to address safety or ethical concerns promptly.
  • Teamwork and Collaboration: Ability to work effectively within a multidisciplinary team. Flexibility and adaptability in a fast-paced research environment.

 

Job Zones

  • Title: Job Zone Five Extensive Preparation Needed
  • Education: Most of these occupations require graduate school. For example, they may require a master's degree, and some require a Ph.D., M.D., or J.D. (law degree).
  • Related Experience: Extensive skills, knowledge, and experience are needed for these occupations. Many require more than five years of experience. 
  • Job Training: Employees may need some on-the-job training, but most of these occupations assume that the person will already have the required skills, knowledge, work-related experience, or training.
  • Job Zone Examples: These occupations often involve coordinating, training, supervising, or managing the activities of others to accomplish goals. Very advanced communication and organizational skills are required. 
  • Specific Vocational Preparation in years: 4-7 years preparation (8.0 and above)

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