Clinical Studies Specialist II
Proclinical is currently recruiting for a Clinical Study Specialist for a biopharmaceutical company located in North Chicago, IL.
- Conduct Phase I-IV studies according to Federal Regulations and ICH guidelines.
- Support clinical team, primarily in tracking, organizing and filing Phase I-IV study documents according to Federal Regulations and ICH guidelines.
- Assist Clinical Team members in handling data queries, drug inventories, study invoice payments, enrollment tracking, and record reconciliation with site documents.
- Assist the CRAs with organizing and planning study investigator meetings.
Skills and Requirements:
- Bachelor's required.
- 3-5 years' relative experience in research site as a Research Coordinator or Regulatory Coordinator, CRO experience as an in-house monitor, Quality Assurance in a Pharmaceutical setting, Trial Master File experience, or Audit/Inspection preparation experience required.
- Tech Savvy regarding data is required.
- Strong written and verbal communication.
- Experience with quality assessment and quality systems.
- Highly organized.
- Excellent oral and written communication skills.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nikki Ranieri at (+1) 215-531-5288 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.