Must possess at least two (2) years’ experience with each of the following: GCP and regulatory compliance guidelines for clinical trials including Clinical Trial Design and Execution (Phase I-IV); Clinical study Start-up, site initiation, monitoring, and close-out; Review and development of ICF, Protocol, and amendments; Patient recruitment and retention strategies, SDV, AE and SAE reporting; FDA Regulations 21 CFR Parts 11, 50, 54, 56, 312, 812, and ICH-GCP (E6 R2/R3) Compliance; IRB/IEC Submission and approval process; CAPA development and implementation, and HIPAA compliance; and CTMS, Veeva Vault CTMS, Oracle Siebel CTMS, and Salesforce. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).