Clinical Study Management Associate

Proclinical is currently recruiting for a Clinical Study Management Associate with a biopharmaceutical company located in North Chicago, IL.

Job Responsibilities:

• Responsible for supporting the planning and execution of one or more Phase 1 - 4 clinical research studies. An SMA performs clinical trial related responsibilities to ensure studies are executed with quality and efficiency, on-time, within budget and in support of company objectives.
• Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and policies and procedures).
• Supports the Study Project Manager in leading the cross functional study team.
• Supports the preparation of Clinical Study Team meetings (Agenda/Minutes).
• Responsible for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
• Supports the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR).
• Supports the vendor selection, scope development, management and oversight of external vendors in compliance with processes and procedures and the applicable regulations.
• Responsible for generating the study related training for the study team, study sites, and vendors for assigned studies.
• Proactively identify and resolve and/or escalate study related issues.

Skills and Requirements:

• Bachelor's Degree -Scientific and/or Healthcare field, equivalent is required: Associate's Degree must have RN degree with relevant experience is acceptable.
• Must have at least 2-4 years of Pharma-related/clinical research related experience and demonstrated a high level of core and technical competencies.
• Possesses good communication skills.
• Competent in application of standard business procedures {Standard operating procedures, International Conference on Harmonization {ICH), Global Regulations, Ethics and Compliance).
• Preferred exposure to study initiation through study completion

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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