Research Assistant I at DM Clinical Research Sugar Land, TX
Behavioral Health Market Context
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Qualifications
- •High school diploma or equivalent required
- •Knowledge of medical terminology required
- •Must be detail-oriented and demonstrate attention to detail
- •Excellent customer service skills
- •Excellent computer skills
- •2 more items(s)
Responsibilities
- •The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials
- •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
- •18 more items(s)
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