Clinical and R&D Data Specialist in Hayward, CA at Apex Life Sciences

Date Posted: 5/13/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Hayward, CA
  • Job Type:
    Other
  • Experience:
    Not Specified
  • Date Posted:
    5/13/2018
  • Job ID:
    830655

Job Description


Clinical and R&D Data Specialist

Summary: Collaborates with various departments on the design, documentation, testing and implementation of clinical, CLSI and R&D Lab data studies.  Develops systems for organizing data to analyze, identify and report trends.  Analyzes the interrelationships of data and defines logical aspects of data sets.  Prepares reports of CLSI tests, Internal Research conducted and clinical trial studies for internal validation and cross validation studies.  May evaluate and resolve issues regarding contents of reports.

This position will assist management in the product evaluation and testing, writing internal or external study procedures and protocols, and drafting study related articles for internal and external use. This position also requires assisting in the setting up of clinical trials and studies, training staff internally and externally, clinical and lab data integrity, tracking of data and documentation, maintenance and calibration of equipment and troubleshooting.

Essential Duties and Responsibilities include the following.  Other duties may be assigned. 

  • Performs Clinical, CLSI and R&D Lab Data analysis using SAS, Minitab, MatLab and other statistical application.
  • Collaborates with R&D, Regulatory/Clinical Affairs, Sales and Marketing, and Quality Assurance on the design, documentation, testing and implementation of studies data
  • Develops systems for organizing data to analyze, identify and report trends
  • Prepares reports of CLSI tests, Internal Research conducted and clinical trial studies for internal validation and cross validation studies.
  • Writes and publishes study related articles.
  • Assists in designing and drafting of product validation protocols, experimental procedures and databases.
  • Documents and tracks experiment protocols and maintains experimental data



•Makes quantitative solutions for testing, including solutions made with whole blood or plasma.


  • Perform literature searches related to product development including biochemistry and pharmaceutical research.
  • Assumes a lead role in setting up clinical trials, train staff and provide troubleshooting assistant for operation of the test and reference instruments
  • Writes technical reports, detailing procedures, outcomes, and observations
  • Assists in monitoring study related clinical and lab data integrity
  • Drafts study related articles for internal or external use
  • Performs validation, calibration and maintenance of laboratory and analytical equipment, including standards-setting
  • Performs system acceptance testing
  • Develops working standards, calibration standards and quality control reference samples
  • Conducts, documents and tracks laboratory experiments
  • Ensures proper documentation is completed to meet quality systems requirements
  • Maintains up-to-date quality control chart for laboratory reference instruments
  • Assists Lab Supervisor in training of internal and external staff related to study related equipment, safety protocols, and test procedures
  • Supports company goals and objectives, policies and procedures, Quality

System Regulation and FDA/MDD regulations.

  • Performs any other duties assigned by Lab Supervisor or other management

Knowledge, Skill and Competency Requirements:

  • 4+ year hands-on lab experience in GLP, GCP analytical environment with minimum supervision
  • Excellent written and oral communication
  • Excellent analytical laboratory skills
  • Excellent knowledge of Microsoft Office Applications (Project, Power Point, Excel, Word), A+ for excellent knowledge with SAS, Minitab and MatLab
  • Ability to work quickly and with a wide variety of individuals, as a team member, and to juggle more than one task at a time
  • Flexibility with work schedule
  • Able to travel
  • Knowledge of FDA Good Manufacturing Practices and Good Laboratory Practices, ISO 13485
  • Ability to work in Biohazard lab environments
  • The Company reserves the right to require all employees to undertake additional or different job responsibilities when necessary to meet business needs.

Education/Experience:

BA or BS – Chemistry, Biochemistry, or Science related field

Supervisory Responsibilities:

This job has no supervisory responsibilities but may assume a lead role on a periodic basis.

This job description does not state nor imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job related duties as requested by management and will also be required to meet safety-related requirements. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

For immediate consideration, please send resumes to khurlbut@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.