Associate Clinical Study Coordinator

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

Job summary

An established industry player is seeking a Clinical Research Coordinator to conduct internal clinical trials in compliance with ICH and GCP guidelines. This engaging role involves collaborating with clinical teams, managing study protocols, and ensuring participant safety. The ideal candidate will have a background in life sciences and experience in clinical research. Join a forward-thinking company that values diversity and inclusion, offering competitive rewards and growth potential in a supportive environment.

Benefits

Health insurance

Life and disability insurance

401(k)

Paid time off

Continuing education

Qualifications

• 1-2 years in clinical research or healthcare environment.
• Knowledge of ICH and GCP guidelines is essential.

Responsibilities

• Conduct internal clinical trials adhering to ICH and GCP guidelines.
• Coordinate with Principal Investigator to recruit study participants.

Skills

Knowledge of ICH guidelines

Knowledge of GCP guidelines

Project coordination

Communication

Attention to detail

Time management

Problem-solving

Independence

Education

Associate's degree in a life science

Bachelor's degree in a life science

Tools

CTMS

EDC

eTMF systems

Job description

Job Summary

Conduct internal clinical trials at Medline Industries, LP in accordance with ICH (International Conference on Harmonization), GCP (Good Clinical Practices) guidelines, and departmental SOPs (Standard Operating Procedures). Collaborate with the Clinical Trial Coordinator team to support activities such as tracking 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 members to create study tools and documents.
2. Conduct internal clinical trials adhering to ICH, GCP guidelines, and SOPs.
3. Coordinate with the Principal Investigator (PI) to recruit study participants, ensure they understand participation requirements, risks, and benefits. Serve as the main contact for participants.
4. Plan study activities in collaboration with the primary CRA and PI, including procurement and management of study products, training, and resource management.
5. Ensure compliance with protocols and procedures, report issues such as 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 clinical study activities and data accurately, maintaining records per document management processes, in collaboration with Clinical Trial Coordinators.
8. Provide ongoing study status updates to Clinical and Medical Affairs, ensuring compliance with applicable laws and regulations.
9. Education: Associate's or Bachelor's degree in a life science (e.g., biology, biomedical, nursing, microbiology, psychology).
   Work Experience: 1-2 years in clinical research, laboratory, or healthcare environment documentation/recording or direct patient care.
   Knowledge/Skills: Knowledge of ICH and GCP guidelines, project coordination, communication, attention to detail, time management, problem-solving, and independence.
10. PREFERRED: Bachelor's degree in a life science, 2-4 years of clinical research experience, exposure to CTMS, EDC, and eTMF systems.

Medline Industries, LP offers a competitive rewards package, continuing education, and growth potential.

The salary range for this position is $63,960.00 - $92,560.00 annually, with actual pay based on experience, education, skills, and location. This role is bonus/incentive eligible.

Benefits include health insurance, life and disability insurance, 401(k), paid time off, and additional benefits for part-time employees. For more details, please refer to our benefits information.

We are committed to diversity and inclusion, valuing the differences each employee brings. Learn more about our Diversity, Equity, and Inclusion initiatives here.

Medline Industries, LP is an equal opportunity employer, evaluating applicants without regard to legally protected characteristics.