Job Description

Job Location Detroit - Southfield, MI 48076

The Research Assistant I 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

Qualifications