Primary Skills: clinical trial, Clinical research, FDA, EMA Regulations, ICH Guidelines, GCPs
Duration: 6+ Months (possible extension)
Tax Term: W2 Only
- Manage all aspects of clinical trial conduct including study start-up, enrollment, study conduct and close-out.
- Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines.
- The position will report to the Associate Director of Clinical Operations.
To follow up with any questions, please contact Vaibhav at 408-512-2355
- At least 5+ years of experience related clinical trial management and a BS or BA in a relevant scientific discipline.
- Clinical research knowledge and cross-functional understanding of clinical trial methodology.
- Proficient in developing trial plans including site monitoring plans, risk mitigation strategies, site selection, and clinical supplies management.
- Attention to detail required.
- Thorough knowledge and understanding of FDA and/or EMA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required.
- Must be able to resolve problems using national and international regulations, guidelines and investigator interaction.
- Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary.
Akraya is an award-winning IT staffing firm and the staffing partner of choice for many leading companies across the US. We offer comprehensive benefits including Health Insurance (medical, dental, and vision), Cafeteria Plan (HSA, FSA, and dependent care), 401(k) (enrollment subject to eligibility), and Sick Pay (varies based on city and state laws).
If this position is not quite what you're looking for, visit akraya.com and submit a copy of your resume. We will get to work finding you a job that is a better fit at one of our many amazing clients.
Akraya is committed to equal treatment and opportunity in all aspects of recruitment, selection, and employment without regard to gender, race, religion, national origin, ethnicity, disability, gender identity/expression, sexual orientation, veteran or military status, or any other category protected under the law. Akraya is an equal opportunity employer; committed to a community of inclusion, and an environment free from discrimination, harassment, and retaliation.