Job Description

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 and wherever applicable. Assisting in the creation of source documents for their assigned protocols at their respective site(s). 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: Medical Assistant Certification preferred. Knowledge & Skills: Knowledge of medical terminology required. Must be detail-oriented and demonstrate attention to detail. #J-18808-Ljbffr DM Clinical Research

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