Clinical Research Coordinator 1

Atlas Family•Corpus Christi, TX

About The Position

The Clinical Research Coordinator (CRC) manages clinical trials conducted under the guidance of the Principal Investigator (PI) and KUR International. This role plays a vital part in the daily execution of clinical studies by ensuring compliance with regulatory guidelines, study protocols, and ethical standards. The CRC is responsible for participant safety, data integrity, and proper implementation of research procedures from screening to study completion.

Requirements

High school diploma required.
Equivalent education can substitute for experience on a year-for-year basis.

Nice To Haves

2+ years of clinical research experience (Phase I–IV).
Strong attention to detail, organization, and multitasking abilities.
Knowledge of HIPAA regulations and informed consent laws.
Familiarity with clinical trial documentation (e.g., 1572, SAE reports, ICFs).
Excellent written and verbal communication skills.
Ability to work independently and collaboratively across teams.
Effective problem-solving and critical thinking skills.
Previous experience using Real-Time CTMS is a plus.
Associate or Bachelor’s degree in science or a related field.

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).
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.
Other duties as assigned.