Location
Jersey City, NJ | United States
Job description
Research 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
Job tags
Salary
