Research Assistant I (Lab)

Dm Clinical Research Group; Tomball (TX); On-site; USD 38,000 - 62,000; Full time

Job summary

Dm Clinical Research Group is seeking a Research Assistant I (Lab) to support clinical trial activities at the site. The role involves assisting the clinical staff with data collection, specimen handling, and adherence to sponsor requirements using the EDC system.

The assistant will help maintain accurate records, prepare regulatory binders, and participate in audits and monitoring visits. A high school diploma is required, with preferred credentials in phlebotomy or medical assisting.

Qualifications

• High school diploma or equivalent is required.
• Experience in clinical research is preferred but not required.
• Phlebotomist certificatepreferred.
• Medical Assistant Certification preferred.
• Knowledge of medical terminology is required.
• Attention to detail is essential.
• Excellent customer service and computer skills are expected.

Responsibilities

• Assist clinical staff in collecting and recording patient data per sponsor requirements.
• Assist in timely collection, management, and shipment of subjects' samples or specimens.
• Maintain accurate, legible records and source documents for assigned protocols.
• Prepare for monitoring visits and audits at site(s).
• Contribute to regulatory binders and trial documentation.
• Support patient visits and reporting of adverse events as required.

Skills

Medical terminology

Detail-oriented

Customer service

Computer skills

Education

High school diploma or equivalent

Job description

The Research Assistant I (Lab) 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