Job Category: Clinical Affairs
Job Number: 11825037
Akraya is looking for a Clinical Project Associate for one of our clients. If the job description below is a fit, please apply directly or call Ashu Pandey & 408-907-2228, If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: Clinical, Regulatory, Administration, ICH, FDA and or EMEA Regulations, GCPs.
Duration: 12 Months (Possibility for Extension)
Contract Type: W2 Only
Qualifications and Skills Required:
- Clinical project associate will work under general new process in quality group.
- Clinical project associate will be responsible for tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
- Processes drug shipments, drug returns, and assists with in-house drug reconciliation.
- Clinical project associate will Order and maintain inventory of clinical supplies.
- Clinical project associate will Order and ship case report forms.
- Assists with development of documents for site binders.
- Assembles and prepares distribution of site binders.
- Clinical project associate will serve as CRA back up providing verbal and written communication with study personnel.
- Clinical project associate will work under close supervision reviews and participates in the quality assurance (CAPA) of data or documents.
- Clinical project associate will arrange meeting for logistics.
- Drafts meeting agendas and assists in preparing meeting minutes. (Interacts with other departments, as directed, to complete assigned tasks.
- Clinical project associate may assist with monitoring visits under the direct supervision of senior staff.
- 2-3+years of experience with BS degree or fresh bachelors with intern experience in a related scientific discipline.
- Would be responsible for interactions and maintenance of documents. (Electronic data management)
- Right candidates are trained as per the requirement of the project.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Must be familiar with Word, PowerPoint, and Excel.
- Knowledge of FDA and or EMEA Regulations, ICH Guidelines, GCPs, and/or familiarity with standard clinical operating procedures is a plus.
- Must be able to work both independently and as part of a team.
Please apply directly with your update resume or call Ashu Pandey at 408-907-2228
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.