Research Assistant III (Lab)

Dynamed Clinical Research LP; Phoenix (AZ); On-site; USD 40,000 - 60,000; Full time

Job summary

Dynamed Clinical Research LP is seeking a Research Assistant III (Lab) to support clinical trials at the site. The role involves assisting in data collection, sample handling, and regulatory documentation under sponsor requirements and current guidelines.

Ideal candidates have a high school diploma (phlebotomy or medical assistant certifications preferred) and attention to detail. Training in GCP/IATA and ongoing learning will be provided as part of the role.

Qualifications

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

Responsibilities

• Completing DMCR-required training, including GCP and IATA.
• Maintaining knowledge of FDA regulations, GCP/ICH guidelines, SOPs, and study protocols.
• Assisting in collection and recording of patient data per Sponsor requirements via the EDC system.
• Shipping and management of subjects' samples per protocol.
• Assisting in preparation for meetings and monitoring visits for assigned protocols.
• Creating source documents and regulatory binders for assigned protocols.
• Conducting patient visits and reporting Adverse Events per Sponsor guidelines.
• Addressing issues from audits and monitoring letters in a timely manner.
• Performing other duties as assigned by management.

Skills

Phlebotomy

Medical terminology

Data entry

GCP knowledge

Education

High school diploma or equivalent

Phlebotomist certificate

Medical Assistant Certification

Tools

EMR/EHR systems

Job description

The Research Assistant III (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