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Research Assistant I

5 months ago

Linden, United States DM Clinical Research Full time
Job DescriptionJob DescriptionResearch Assistant I
 

The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials. 

DUTIES & RESPONSIBILITIES

  • Completing DMCR-required training, including GCP and IATA.
  • Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
  • Assisting in the collection and recording of patient data per Sponsor requirements via the respective EDC system.
  • Timely and accurately assist in collection, management, and shipment of subjects' samples, and/or specimens
  • Completing Sponsor-required training prior to study-start, including, but not limited to
    • Sponsor-provided and IRB-approved protocol
    • All amendments
    • Investigator Brochure
    • Sponsor-specified EDC and/or IVRS
  • This includes completing the above-mentioned training prior to any study-related procedures being conducted on that said protocol should the RA be added to a protocol post-study start.
  • Maintaining clear, concise, accurate, and legible records.
  • Being prepared for and available at all required company meetings and monitoring visits for their assigned protocols at their respective site(s).
  • Utilizing the most recent version of the Protocol, Informed Consent, and Investigator Brochures at their respective site(s).
  • Assisting in the compilation and organization of all regulatory and administrative binders for their assigned protocols at their respective site(s) upon initial receipt of and wherever applicable.
  • Assisting in the creation of source documents for their assigned protocols at their respective site(s).
  • Conducting patient visits.
  • Assisting in reporting Adverse and Serious Adverse Events to the appropriate authorities per Sponsor. 
  • Assisting in addressing and resolving issues from internal/external audits and monitoring letters for all assigned protocols at their respective site(s) in a timely manner.
  • Assists with all other aspects of the study and conducts as needed.
  • Any other matters as assigned by management.

 

KNOWLEDGE & EXPERIENCE

Education:

  • High school diploma or equivalent required

Experience:

  • Prior experience in clinical research is not required but preferred

Credentials:

  • Phlebotomist certificate preferred
  • Medical Assistant Certification preferred

Knowledge & Skills:

  • Knowledge of medical terminology required
  • Must be detail-oriented and demonstrate attention to detail
  • Excellent customer service skills
  • Excellent computer skills

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