Research Assistant II (Lab) (3715)
About The Position
The Research Assistant II (Lab) will be responsible for assisting the clinical research staff in conducting clinical research trials and assisting in the pre-screening process. This role involves maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols. The assistant will help in the collection and recording of patient data, management and shipment of samples, and ensuring clear, concise, and accurate records. They will also be involved in patient visits, reporting adverse events, and assisting with audits and monitoring visits.
Requirements
- High school diploma or equivalent required
- 1-2+ years experience in the clinical field
- Knowledge of medical terminology required
- Must be detail-oriented and demonstrate attention to detail
- Excellent customer service skills
- Excellent computer skills
- Patient-centric focus.
- Strong organizational and time-management skills.
- Able to work in a fast-paced environment ensuring limited oversights.
Nice To Haves
- Phlebotomist certificate preferred
- Medical Assistant Certification preferred
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.
- 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.
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What This Job Offers
Career Level
Mid Level
Education Level
High school or GED
