Symbio, LLC is a small but busy and vibrant Contract Research Organization. We are currently in search of a full-time GCP Compliance Manager to work from home office. This position will involve travel (<50%) and will function independently from Symbio, LLC departments that fall under Clinical Operations. This individual will be responsible for assessing and assuring that company Standard Operating Procedures (SOPs), GCP Compliance along with related Food and Drug Administration (FDA) regulations/guidelines, International Conference on Harmonization (ICH) regulations/guidelines, and any other relevant regulations are adhered to.
A Bachelor’s Degree in a Science related field and specific training related to regulatory/compliance requirements and practices are required. The individual must have strong knowledge of FDA/ICH GCPs and at least 10 years experience in GCP QA function, along with 3-5 years quality/compliance management experience. Experience in conducting audits of computer systems, investigative sites, and clinical study databases are required. Excellent communication skills, both written and verbal, are a must. This person must be able to work independently and have excellent attention to detail. Proficiency in Microsoft Word and Excel is also required.
Symbio, LLC is a small but busy and vibrant Contract Research Organization based out of Port Jefferson, NY. Our services are extensive and complete, and range from the following:Pre-Study, including Protocol Development, Site Identification and Qualification, Study Planning and Set-up, Regulatory Collection and IRB Submission, and Coordinate Investigator Meetings; Study Management, including Stud...y Initiation, Ongoing Communication, Monitoring Visits and Reports, and SAE Notification; and Post-Study including, Data Management/Statistics, Final Reporting, and Document Archiving.At Symbio, our motto is…Exceeding Expectations in Clinical Trials