Clinical Research Coordinator II

Kelly Science, Engineering, Technology & Telecom

Spokane, Coeur d'Alene (WA, ID)

Vor Ort

USD 58.000 - 85.000

Vollzeit

Vor 2 Tagen
Sei unter den ersten Bewerbenden
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Zusammenfassung

Kelly® Science & Clinical is seeking a Clinical Research Coordinator II for a Temp-to-Hire opportunity in Spokane, Washington. You will independently coordinate trials from startup through close-out, serving as a primary contact for study teams while ensuring protocol adherence and data integrity.

This on-site role requires 18+ months of direct clinical trial experience, strong knowledge of GCP/ICH and HIPAA, and the ability to manage multiple studies with limited supervision.

Qualifikationen

  • At least 18 months of direct clinical trial experience in a coordinator or similar role.
  • Experience with participant visits, source docs, EDC entry, monitoring, and protocol compliance.
  • Current or ability to complete CITI and GCP training before study delegation.
  • Strong knowledge of HIPAA, GCP, ICH guidelines, and source-documentation standards.

Aufgaben

  • Coordinate day-to-day clinical trial activities from startup through close-out.
  • Serve as operational contact for participants, investigators, sponsors, CROs, and monitors.
  • Prepare for and conduct participant visits per protocol and regulatory requirements.
  • Maintain audit-ready source documentation and support data reconciliation.

Kenntnisse

Clinical trial coordination
GCP knowledge
EDC data entry
Regulatory compliance
Communication
Attention to detail

Ausbildung

Bachelor’s degree in health or science

Tools

EDC systems
CTMS/eSource
EMR systems
Microsoft Office
Sponsor portals

Jobbeschreibung

Kelly® Science & Clinical is seeking a Clinical Research Coordinator for a Temp-to-Hire opportunity supporting research site client. If you are an experienced clinical research leader who is dedicated to advancing high-quality research, upholding Good Clinical Practice, and thriving in a fast-paced, professional environment, trust The Experts at Hiring Experts to guide your next career move.

Clinical Research Coordinator II — Temp-to-Hire (possible direct hire, dependent on exp)

Local Candidates only

What You’ll Do

As a Clinical Research Coordinator II, you will independently coordinate assigned clinical trials from startup through close-out. You will serve as a key operational contact for study participants, investigators, sponsors, CROs, monitors, and internal research teams while ensuring protocol adherence, data integrity, participant safety, and inspection-ready documentation.

Key responsibilities include:

  • Coordinate day-to-day clinical trial activities, including screening, enrollment, participant visits, follow-up, monitoring, and close-out activities.
  • Prepare for and conduct participant visits in accordance with study protocols, GCP, ICH guidelines, HIPAA, site SOPs, and sponsor requirements.
  • Track eligibility, enrollment, visit windows, study milestones, protocol-required follow-up, and scheduling needs.
  • Maintain accurate, complete, timely, and audit-ready source documentation in alignment with ALCOA principles.
  • Enter data into EDC and sponsor systems; reconcile source data, resolve queries, and support database-lock readiness.
  • Identify, document, and identify protocol deviations, adverse events, serious adverse events, safety concerns, and data-integrity issues.
  • Support informed-consent processes under Principal Investigator oversight and provide clear education to participants and caregivers.
  • Serve as a primary contact for sponsors, CROs, monitors, vendors, and study participants for assigned trials.
  • Prepare for and support site initiation, monitoring, remote monitoring, audit, and close-out visits.
  • Coordinate study supplies, lab kits, specimen processing and shipment, study equipment, and protocol-required assessments.
  • Partner with regulatory staff on study startup, amendments, continuing reviews, safety reporting, and close-out documentation.
  • Help mentor junior research staff and contribute to process improvements, quality reviews, and team training.
Required Qualifications
  • At least 18 months of direct clinical trial experience in a clinical research coordinator, research nurse, clinical research assistant, data coordination, regulatory, or comparable clinical research role.
  • Demonstrated experience with participant visits, source documentation, EDC data entry, monitoring visits, and protocol compliance.
  • Current or ability to complete CITI Human Subjects Protection and Good Clinical Practice (GCP) training before study delegation.
  • Strong knowledge of clinical trial operations, informed consent, protocol adherence, HIPAA, GCP, ICH guidelines, and source-documentation standards.
  • Ability to manage multiple studies, competing deadlines, participant needs, and sponsor expectations with limited supervision.
  • Strong communication, organization, prioritization, and attention-to-detail skills.
  • Comfort using EDC systems, sponsor portals, CTMS/eSource platforms, EMR systems, Microsoft Office, and electronic scheduling tools.
  • Ability to work fully on-site in Spokane, Washington.
Preferred Qualifications
  • Bachelor’s degree in health, science, or a related field.
  • Three or more years of progressive clinical research coordination experience.
  • Experience independently managing interventional drug, device, infusion, imaging, or biospecimen-heavy clinical trials.
  • Experience in neurology, movement disorders, CNS trials, Parkinson’s disease, Huntington’s disease, neurodegenerative disorders, or related patient populations.
  • Experience supporting sponsor audits, CAPAs, database lock, or inspection-readiness activities.
  • CCRC, CCRP, or comparable clinical research certification.
  • Phlebotomy certification and/or relevant clinical licensure or certification, such as RN, LPN, or MA.

This is a fully on-site role in a professional clinical research setting, with work occurring across office, exam room, laboratory, and procedure areas. The position requires frequent interaction with participants, caregivers, investigators, sponsors, monitors, CROs, and vendors. Occasional early-morning, late-afternoon, weekend, or protocol-driven scheduling may be required.

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