Clinical Research Assistant

GI Alliance; Town of Germantown (WI); Sur place; USD 52 000 - 76 000; Plein temps

Résumé du poste

Paycom in Wisconsin seeks a Clinical Research Coordinator to support study protocols, obtain consent, and ensure regulatory compliance. You will work closely with study teams to screen candidates, document procedures, and maintain source data in EDC and EMR systems.

Responsibilities include coordinating visits, collecting specimens, performing measurements, managing inventory, and communicating with sponsors, IRB, and investigators. Strong knowledge of HIPAA, GCP, and FDA regulations is required.

Qualifications

• Experience coordinating clinical trials and obtaining patient consent.
• Knowledge of GCP, FDA regulations, and IRB processes.
• Ability to maintain source documents and data entry in EDC/EMR systems.

Responsabilités

• Read and understand protocol requirements and informed consent forms.
• Screen candidates and obtain informed consent per protocol.
• Maintain source documents and case report forms in accordance with sponsor requirements.
• Collect and process study-related data and specimens per protocol.
• Coordinate with study team, IRB, sponsors, and investigators.
• Ensure HIPAA compliant communication and confidentiality at all times.
• Assist with site initiation, monitoring, and close-out visits as needed.
• Provide training compliance and ongoing education as required.

Connaissances

Clinical trial coordination

IRB knowledge

GCP familiarity

HIPAA compliance

EMR/EDC data management

Outils

EDC

EMR systems

MS Office

Description du poste

Read and understand specific requirements of each study protocol and informed consent formWorks with study coordinators and other research team members to complete protocol specific procedures and documentationAssists in clinic and protocol administration duties including but not limited to:Explain the purpose, risks, and benefits of clinical trial participationScreen potential candidates in a timely and accurate mannerEnsure that study patients understand the information presented and agree to the protocol requirementsObtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standardsProvide instructions to patients to ensure proper protocol complianceDistribute study medications in compliance with protocol randomization requirementsLearn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirementsPerform study-specific readings and measurements including but not limited to:Vital signsECGUrine Pregnancy TestUroflow, TRUS, urinalysis, cystoscopyPhotography and videographyReports irregular readings and measurements to Investigator and Lead Study CoordinatorPackage and ship laboratory specimens to study-specific destinationsComplete applicable training requirements and ongoing education as requiredMaintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.Communicate with and support patients and their families as necessary.Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain recordsEffectively communicate with potential candidates for trials and collect metrics to track progressMust have or gain knowledge of relevant software/programsWork closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and callsAssist with the development of source documents and phone screen toolsManage ancillary supply inventory and assist with drug accountabilityMaintain HIPAA compliant communication and confidentiality, at all timesParticipate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.Assist study coordinators with necessary study close-out procedures and documentationPerforms other duties as assigned