Research Assistant I (Non-Lab) (4381)

Paycom - ATS; Tomball (TX); On-site; USD 42,000 - 52,000; Full time

Job summary

The Research Assistant position at Paycom - ATS in Tomball, TX supports clinical research staff in conducting trials, data collection, regulatory binders, and source document creation.

Ideal candidates have a high school diploma; phlebotomist or medical assistant certification preferred; training in GCP, IATA, and FDA regulations; strong attention to detail and good computer skills.

Qualifications

• High school diploma or equivalent required.
• Phlebotomist certificate preferred.
• Medical Assistant Certification preferred.

Responsibilities

• Complete DMCR-required training including GCP and IATA.
• Maintain knowledge of current FDA regulations, GCP/ICH guidelines, SOPs, and study protocols.
• Assist in collecting and recording patient data per Sponsor requirements via the EDC system.
• Assist in collection, management, and shipment of subjects' samples and/or specimens.
• Prepare regulatory and administrative binders for assigned protocols.
• Create source documents for assigned protocols.
• Conduct patient visits and assist in reporting adverse events.
• Support audits and monitoring visits for assigned protocols.

Skills

Medical terminology

Detail oriented

Customer service

Computer skills

Education

High school diploma or equivalent

Tools

EDC system

IVRS

Job description

Job Details: Job Location: Tomball 13414 STE 10 - TRA - Tomball, TX 77375, The Research Assistant 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