Associate Clinical Study Coordinator

Job Summary

JOB SUMMARY Conduct internal clinical trials executed at Medline Industries, LP in accordance with ICH (International Committee for Harmonization), GCP (Good Clinical Practices) guidelines, and departmental and Medline Industries, LP. SOPs (Standard Operating Procedures). Collaborates with Clinical Trial Coordinator team to support other Clinical Operations activities such as coordination and tracking of investigational product, documents, and assets.

Job Description

MAJOR RESPONSIBILITIES

• Participates as needed in Internal study protocol development and Institutional Review Board submissions as well as collaborates with other Clinical Operations team members to create any needed study tools and documents.
• Conduct Internal clinical trials executed at Medline Industries, LP in accordance with ICH (International Committee for Harmonization), GCP (Good Clinical Practices) guidelines, and departmental and Medline Industries, LP. SOPs (Standard Operating Procedures).
• In coordination with Principle Investigator (PI), recruit study participant, ensure understanding of participation requirements, and any possible risks or benefits of the study. Main point of contact for study participant.
• In coordination with primary CRA and PI, plans all study execution activities, study product procurement and accountability management, any necessary training for protocol execution, execution practice sessions, and resource management.
• Ensure all protocol and procedures are followed. Gather, communicate problems (ex. protocol deviations), and determine best course of action.
• Execute delegated protocol study activity including participant pre-screening and screening activity, participant scheduling, monitor study participant safety throughout the trial, and coordinate communications between other members of the clinical research team.
• Accurately documents (on paper or in electronic systems) all clinical study activities and data collection. Maintains records in coordination with established document management processes and in collaboration with Clinical Trial Coordinators (CTC/Sr. CTC)
• Provides Clinical Affairs and Medical Affairs ongoing study status updates. - Ensure compliance with local and federal law and research regulations/guidance.
• Education - Associates or Bachelor's degree in a life science (ex. biology, biomedical, nursing, microbiology, psychology). Certification / Licensure - None required.
• Work Experience - At least 1-2 years of experience documenting or recording Information in a clinical research, laboratory or quality assurance environment OR providing direct patient care in a healthcare environment.
• Knowledge / Skills / Abilities - Knowledge of ICH and GCP guidelines.
• Experience controlling and coordinating concurrent projects, competing priorities and critical deadlines.
• Experience assessing and responding productively to change in a timely manner.
• Strong Communication skills.
• Attention to detail.
• Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates. - Independent/self-directed/problem solving-solutions oriented
• PREFERRED JOB REQUIREMENTS - Bachelor's degree in a life science (ex. biology, biomedical, nursing, microbiology, psychology). - 2-4 years of experience in a clinical research role with exposure to ICH and GCP guidelines. - Exposure to CTMS, EDC (Electronic Data Capture), and eTMF.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

$63,960.00 - $92,560.00 Annual

The actual salary will vary based on applicants location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here . For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Every day, were focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing whats right to delivering business results, together, were better. Explore our Diversity, Equity and Inclusion page here .

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.