Research Assistant I (Lab) (4170)

The Research Assistant I (Lab) will be responsible for assisting the clinical research staff in conducting clinical research trials.

DUTIES & 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

- 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.

KNOWLEDGE & EXPERIENCE

Education:

- High school diploma or equivalent required

Experience:

- Prior experience in clinical research is not required but preferred

Credentials:

- Phlebotomist certificate preferred

- Medical Assistant Certification preferred

Knowledge & Skills:

- Knowledge of medical terminology required

- Must be detail-oriented and demonstrate attention to detail

- Excellent customer service skills

- Excellent computer skills