Clinical Trial Assistant

Job Description

Job Description

Clinical Trial AssistantThis is an on-site, in-office position at Geneoscopy HQ in St. Louis, Missouri.The Clinical Trial Assistant (CTA) provides administrative and operational support for clinical research studies conducted in accordance with federal regulations, Good Clinical Practice (GCP), institutional policies, and study protocols. The CTA assists research coordinators, project managers, investigators, sponsors, and study participants by maintaining regulatory documentation, coordinating study activities, tracking study milestones, and ensuring accurate data and records management.This position serves as an integral member of the clinical research team and contributes to the successful execution of clinical trials while maintaining participant confidentiality and regulatory compliance.RESPONSIBILITIESStudy Administration:Assist with day-to-day coordination of clinical research studiesSchedule study visits, calls, and participant follow-up activitiesPrepare study materials and participant packets (informed consents)Coordinate shipment and receipt of study suppliesTrack study enrollment and participant statusMaintain study calendars and visit schedulesRegulatory Support:May assist with maintaining Investigator Site Files (ISF) and regulatory binders.May assist with IRB submissions, amendments, continuing reviews, and reportable eventsOrganize essential documents according to GCP guidelinesTrack regulatory approvals and expiration datesEnsure study documentation is complete and audit-readyData Management:Assist with entry of study data into electronic data capture (EDC) systemsReview source documentation for completenessAssist with query resolutionMaintain study tracking logs and screening logsEnsure timely and accurate documentationParticipant Support:Assist with participant recruitment activitiesConduct reminder phone calls, emails, and appointment confirmationsPrepare informed consent documents for coordinator reviewCollect questionnaires and study formsMaintain participant confidentiality in accordance with HIPAA regulationsLaboratory and Specimen Support:Prepare specimen collection kitsCoordinate specimen shippingMaintain specimen inventory logsTrack laboratory suppliesAdministrative:Maintain study correspondenceAssist with sponsor monitoring visits and auditsCoordinate document requestsCompliance:Follow Good Clinical Practice (ICH-GCP) guidelines.Maintain HIPAA compliance.Adhere to institutional SOPs.Protect participant confidentiality.Complete required research training.Support quality assurance initiatives.Assist during internal and external audits.Other duties as assigned.EDUCATION REQUIREMENTSBachelor 's degree in Biology, Health Sciences, Public Health, Nursing, Psychology, or a related field is preferred.Associate 's degree with relevant work experience may be considered.QUALIFICATIONSPossess 0-2 years of clinical research experience in a healthcare, laboratory, or administrative setting.Demonstrate a basic understanding of clinical research processes, Good Clinical Practices (GCPs), HIPAA regulations, IRB requirements, and the informed consent process.Exemplify hands-on experience with Google Workspace, Adobe Acrobat, Database management, and file organization.Knowledge of Electronic Medical Records (EMR) and Electronic Data Capture (EDC) systems.Exemplify the ability to multitask and thrive in an agile, fast-paced, deadline-driven environment while remaining flexible, proactive, resourceful, and efficient.Possess proficient verbal and written communication skills, while willing to share and receive information and ideas from all levels of the organization to achieve the desired results.Possess high ethics and conduct business in the most professional manner.Seek inclusiveness and collaboration but step up to responsibility, make tough decisions, and be accountable for those decisions.Act as a results-oriented team player with strong interpersonal and communication skills, capable of working collaboratively with colleagues.Preferred Additional Experience:CITI Human Subjects Protection trainingGCP certificationSupporting FDA-regulated clinical trialsReading medical records/pathology reportsClinical trial documentationCollaborating with sponsors or Vendors SCHEDULEThis is a salaried position, requiring at least 40 hours per week. There may be projects that require activities beyond the standard hours.COMPENSATION & BENEFITSBase salary range: annually determined based on the candidate's experience, knowledge, and abilities.Bonus: discretionary annual bonus based on a percentage of the employee's base salaryBenefits: health, vision, dental, life insurance, 401k (with employer match), and paid time off.Company stock options ADDITIONAL INFORMATION Geneoscopy's Core ValuesAbility to embody Geneoscopy's beliefs, philosophies, and principles:Integrity - we do the right thing through our words, actions, and behaviorsCourage - step up, speak up, stand outAgility - think and act fast, embracing changePassion - for our customers, our people, our work, and for excellenceCollaboration - our differences are assetsPhysical DemandsEmployees may be required to lift routine office supplies and use standard office equipment.Must possess the ability to sit and/or stand for long periods.Must possess the ability to perform repetitive motion.Work EnvironmentMay have exposure to fumes anbiohazardousus material in the laboratory environment.May be required to handle blood-borne pathogens and general laboratory reagents. By completing this online employment application, you certify that the information on this application is true and complete to the best of your knowledge. You understand that any misrepresentation or omission of fact in response to any inquiry made in this application may result in the rejection of the application or if hired, dismissal whenever it is discovered. You authorize and release all parties from any liability or damage that may result from seeking, furnishing, or using such information. You understand and agree that, if hired, your employment is for no definite period and may, regardless of the date of payment of compensation, be terminated by Geneoscopy at any time, for any or no reason, with or without notice. You understand that no representation to the contrary is valid unless in writing, setting a definite term of employment, and signed by the company's CEO. You further understand and agree that any job offer is contingent upon your passing, to the company's satisfaction, a criminal background check, reference checks, and other possible screenings. You understand that this application is active for 90 days only, and if you do not hear from the company but still wish to be considered for employment after 90 days, you will need to fill out a new application.