The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials.
Job Responsabilities:
1) Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
2)Assisting in the collection and recording of patient data per Sponsor requirements via the respective EDC system.
3)Timely and accurately assist in collection, management, and shipment of subjects' samples, and/or specimens
4) Completing Sponsor-required training prior to study-start
5) Maintaining clear, concise, accurate, and legible records.
6) Assisting in the compilation and organization of all administrative binders for their assigned protocols
7) Conducting patient visits (prescreening and screening visits)
8) Assisting in reporting Adverse and Serious Adverse Events to the appropriate authorities per Sponsor.
9) 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.
10) Assists with all other aspects of the study and conducts as needed.
11) Assist the team in conducting EKG/ECGs.
12) Assist the lab team in blood drawing, lab processing and shipping. As well as completing and mantaining study logs, vendor lab requisitions and source documents.
13) Able to manually take patient blood pressure.
14) Assists in conducting rapid clinical tests.
15) Any other matters as assigned by management.
15) Oversee all of the Research Assistant(s) workflow ensuring all projects and tasks are completed efficiently, accurately, and effectively.
Knowledge and Expirience:
1) Education:
Bachelor’s Degree in a medical field or Foreign Medical Graduate (FMG/IM), required
2) Experience:
3+ years in the clinical field, required
1+ years in clinical research in the US, preferred
Phlebomoty expirence, required
3) Credentials:
Phlebotomist certificate, preferred
IV Administration Certification, preferred
4) 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.
Ability to lift 20lbs
Ability to assist in diferent postions
Bilingual, Fluent in English (required) and Spanish (preferred)
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