Research Assistant III (3593)

DM CLINICAL RESEARCH GROUP•Bradenton, FL

1d•Onsite

About The Position

The Research Assistant III will be responsible for assisting the clinical research staff in conducting clinical research trials. This role involves a variety of duties including completing required training, maintaining knowledge of regulations, collecting and recording patient data, managing and shipping samples, and ensuring accurate record-keeping. The position also requires participation in company meetings, monitoring visits, and assisting in the compilation of regulatory binders and creation of source documents. Additionally, the Research Assistant III will conduct patient visits, report adverse events, and assist with audits and monitoring letters. Specific tasks include assisting the lab team with EKGs, blood draws, lab processing, taking blood pressure manually, conducting rapid clinical tests, and assisting coordinators with pre-screening and IV administration. A key responsibility is overseeing the workflow of other Research Assistants to ensure efficient and accurate task completion.

Requirements

High school diploma or equivalent, required
Bachelor’s Degree in a medical field or Foreign Medical Graduate, required
3+ years in the clinical field, required
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.

Nice To Haves

Phlebotomist certificate, preferred
Medical Assistant Certification, preferred
IV Administration 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, and 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.
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.