Associate Clinical Study Coordinator

Medline Industries, Inc. in; Northfield (IL); On-site; USD 63,000 - 93,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Associate Clinical Study Coordinator, der interne klinische Studien leitet und sicherstellt, dass alle Aktivitäten den höchsten Standards entsprechen. In dieser Rolle arbeiten Sie eng mit dem Clinical Trial Coordinator Team zusammen, um die Entwicklung von Studienprotokollen zu unterstützen und die Rekrutierung von Teilnehmern zu koordinieren. Sie werden die Möglichkeit haben, Ihre Fähigkeiten in einem dynamischen Umfeld weiterzuentwickeln und einen bedeutenden Beitrag zur klinischen Forschung zu leisten. Wenn Sie eine Leidenschaft für die Lebenswissenschaften und klinische Studien haben, ist dies die perfekte Gelegenheit für Sie.

Benefits

Gesundheitsversicherung

401(k)

Bezahlter Urlaub

Fortbildungsmöglichkeiten

Qualifications

• 1-2 Jahre Erfahrung in klinischer Forschung oder direkter Patientenversorgung.
• Kenntnisse der ICH- und GCP-Richtlinien.

Responsibilities

• Durchführung interner klinischer Studien gemäß ICH, GCP und SOPs.
• Koordination mit dem Hauptprüfer zur Rekrutierung von Studienteilnehmern.

Skills

Kommunikationsfähigkeiten

Aufmerksamkeit für Details

Zeitmanagementfähigkeiten

Fähigkeit, mehrere Projekte zu verwalten

Education

Associate's oder Bachelor's Degree in Lebenswissenschaften

Bachelor's Degree in Lebenswissenschaften (bevorzugt)

Tools

CTMS

EDC

eTMF

Job description

Associate Clinical Study Coordinator (Project Management)

Job Summary

Conduct internal clinical trials at Medline Industries, LP in accordance with ICH (International Council for Harmonization), GCP (Good Clinical Practices) guidelines, departmental SOPs, and Medline policies. Collaborate with the Clinical Trial Coordinator team to support other Clinical Operations activities such as coordination and tracking of investigational products, documents, and assets.

Job Description

MAJOR RESPONSIBILITIES

1. Participate in internal study protocol development, Institutional Review Board submissions, and collaborate with Clinical Operations team to create study tools and documents.
2. Conduct internal clinical trials following ICH, GCP, SOPs, and departmental standards.
3. Coordinate with Principal Investigator (PI) to recruit study participants, ensure understanding of participation requirements, and communicate risks and benefits. Serve as the main contact for study participants.
4. Plan study activities, manage study product procurement and accountability, organize training sessions, and oversee resource management in coordination with the primary CRA and PI.
5. Ensure adherence to protocols and procedures. Identify problems such as protocol deviations and determine corrective actions.
6. Execute delegated study activities including participant pre-screening, scheduling, safety monitoring, and communication with the research team.
7. Document all study activities and data accurately in paper or electronic systems, maintaining records according to document management policies and in collaboration with Clinical Trial Coordinators.
8. Provide ongoing study status updates to Clinical and Medical Affairs teams. Ensure compliance with applicable laws and regulations.
9. Qualifications:
   • Associate's or Bachelor's degree in a life science (e.g., biology, biomedical, nursing, microbiology, psychology).
   • 1-2 years of experience in clinical research, laboratory, quality assurance, or direct patient care.
   • Knowledge of ICH and GCP guidelines.
   • Strong communication, attention to detail, and time management skills.
   • Ability to handle multiple projects and adapt to change independently.
10. PREFERRED:
    • Bachelor's degree in a life science.
    • 2-4 years of clinical research experience with exposure to CTMS, EDC, and eTMF.

Medline offers a competitive rewards package, continuing education, and growth opportunities. The salary range is $63,960 - $92,560 annually, with actual compensation based on experience and location. Benefits include health insurance, 401(k), paid time off, and more.

We are committed to diversity and inclusion. Medline Industries, LP is an equal opportunity employer.