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KUR Research · 1 day ago

Clinical Research Coordinator 1

Corpus Christi, Texas, United States

Full-time

Onsite

Entry, Mid Level

2+ years exp

KUR Research is focused on conducting clinical trials and they are seeking a Clinical Research Coordinator to manage these trials. This role involves ensuring compliance with regulatory guidelines, participant safety, and proper implementation of research procedures from screening to study completion.

Health CareHospitalMedicalPrimary and Urgent Care

Responsibilities

Coordinate and manage daily operations of multiple clinical trials

Collaborate with PIs, Sub-Investigators, KUR staff, participants, sponsors, and CROs

Ensure compliance with FDA, GCP/ICH guidelines, study protocols, and KUR SOPs

Recruit and screen potential study participants; maintain recruitment documentation

Obtain informed consent under PI supervision using current IRB-approved forms

Verify eligibility criteria and ensure proper documentation before enrollment

Schedule and manage participant visits throughout the study lifecycle

Review created source document templates and manage subject data

Timely completion of case report forms and resolution of queries

Manage investigational products including receipt, storage, and disposition

Support study monitor visits, audits, and inspections, ensuring availability of all required documentation

Complete all required training (e.g., GCP, IATA, SOPs) within set timelines and maintain current certification annually

Uphold confidentiality and regulatory requirements (e.g., IRB compliance, informed consent, HIPAA, privacy regulations)

Other duties as assigned

Maintain clear and consistent communication with all stakeholders (IRBs, sponsors, vendors)

Participate in team calls and provide site-specific updates or remote support

Monitor study progress and ensure adherence to data retention policies

Support proper closure of studies, including return or destruction of study materials

Maintain temperature logs and calibration records, report anomalies promptly

Respond promptly to emails from sponsors, CRAs, and KUR team members

Coordinate with cross-functional departments including Regulatory, QA, Legal, Finance, and BD

Complete and maintain all required training (GCP, HSC, RCR, COI, IATA, ICH, CRC, etc)

Manage third-party vendor relationships (e.g., couriers, dry ice suppliers)

Maintain adequate stock of site and sponsor-specific supplies

Keep workspace organized and professional

Foster a positive and collaborative work environment with KUR and clinic staff

Perform additional duties as assigned

Proficiency with Electronic Data Capture platforms (e.g., iMedidata, Medrio, ClinTrak, Zelta)

Experience with CTMS (preferably Real-Time CTMS), Microsoft Office Suite, Teams, DocuSign, PDF editing tools

Conduct basic clinical procedures (e.g., vitals, ECGs, labs) as required

Collect, process, and ship biological specimens per protocol

Completion of required certifications within two weeks of hire (training provided): GCP, HSC, RCR, COI, IPS, IATA, ICH, CRC

Qualification

Clinical trial managementElectronic Data CaptureGCP certificationCTMS experienceHIPAA knowledgeCommunication skillsAttention to detailProblem-solving skills

Required

High school diploma required