The Research Assistant III 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
Assist the lab team in conducting EKG/ECGs.
Assist the lab team in blood drawing and lab processing
Able to manually take patient blood pressure.
Assists in conducting rapid clinical tests.
Any other matters as assigned by management.
Oversee all of the Research Assistant(s) workflow ensuring all projects and tasks are completed efficiently, accurately, and effectively
Assist coordinators with pre-screening basics and assist with administering patient IVs.
Any other matters as assigned by management.
Knowledge & Experience
Education:
High school diploma or equivalent, required
Bachelor’s Degree in a medical field or Foreign Medical Graduate, required
Experience:
3+ years in the clinical field, required
Credentials:
Phlebotomist certificate, preferred
Medical Assistant Certification, preferred
IV Administration 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
Ability to manage multiple projects at a time
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Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Internet Publishing
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