Research Assistant I (Non-Lab)

DM CLINICAL RESEARCH GROUP•Tomball, TX

3d•Onsite

About The Position

The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials. This role involves completing required training, maintaining knowledge of regulations and protocols, and assisting in the collection and recording of patient data. The assistant will also manage and ship samples, ensure accurate record-keeping, and participate in patient visits and reporting of adverse events.

Requirements

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

Nice To Haves

Prior experience in clinical research is preferred
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.
Any other matters as assigned by management.