Clinical Research Associate
Proclinical is currently recruiting for a Clinical Research Associate with a biopharmaceutical company located in North Chicago, IL.
Responsible for executing all elements of externally sponsored research in compliance with quality standards (ICH/GCP, Global Regulations, (e.g., drug supply management, ICBs, reviews and approves HCP invoices/ payments against executed contracts) with minimal oversight and guidance.
- Responsible for management of clinical essential documents and critical regulatory documents for assigned projects/studies to ensure document packets for study start-up are complete and accurate and consistent with the study start-up timeline.
- Routinely interact with Evidence Leads on assigned projects and in meetings.
- Supports the preparation of Scientific Review Meetings (Agenda/ Meeting Materials).
- Supports on audit/ inspection activities for GCP requirements.
- Responsible for regular updates appropriate for cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
- Participates in process improvement initiatives.
Skills and Requirements:
- At least 4-6 years pharma related research experience
- Bachelor's degree
- Knowledge of externally sponsored research (IIS, external research collaborations)
- Knowledge of clinical study execution
- Knowledge of Good Clinical Practices and ICH/Guidelines, and/or other Global Regulations
- Excellent organizational skills, attention to detail, and strong oral and written communications skills
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
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.