Research Assistant I (Non-Lab)

Paycom - ATS; Tomball (TX); On-site; USD 36,000 - 54,000; Full time

Job summary

Paycom - ATS is seeking a Research Assistant to support clinical trial activities, including data collection, sample handling, and regulatory documentation. The role requires attention to detail, good customer service, and familiarity with medical terminology.

The successful candidate will work with the clinical research team to ensure compliance with GCP/IATA, FDA guidelines, and Sponsor requirements across assigned sites, while maintaining training and documentation accuracy.

Qualifications

• High school diploma or equivalent required.
• Phlebotomist certificate preferred.
• Medical Assistant Certification preferred.
• Knowledge of medical terminology required.

Responsibilities

• Assist clinical staff in conducting clinical trials.
• Maintain training in GCP, IATA, and FDA guidelines.
• Collect and record patient data per Sponsor requirements in the EDC system.
• Assist in collection, management, and shipment of specimens.
• Maintain accurate regulatory and administrative binders for protocols.

Skills

Medical terminology

Attention to detail

Customer service

Computer skills

Education

High school diploma or equivalent

Tools

EDC system

Phlebotomy equipment

Job description

The Research Assistant will be responsible for assisting the clinical research staff in conducting clinical research trials.DUTIES & RESPONSIBILITIESCompleting 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 specimensCompleting Sponsor-required training prior to study-start, including, but not limited toSponsor-provided and IRB-approved protocolAll amendmentsInvestigator BrochureSponsor-specified EDC and/or IVRSThis 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 & EXPERIENCEEducation:High school diploma or equivalent requiredExperience:Prior experience in clinical research is not required but preferredCredentials:Phlebotomist certificate preferredMedical Assistant Certification preferredKnowledge & Skills:Knowledge of medical terminology requiredMust be detail-oriented and demonstrate attention to detailExcellent customer service skillsExcellent computer skills