Job Category: Clinical Affairs
Job Number: 11825035
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, Clinical research. Clinical trial, ICH, FDA and or EMEA Regulations, GCPs, TMF, eTMF
Duration: 12 Months (Possibility for Extension)
Contract Type: W2 Only
- May assist in the development and upkeep of administrative support tools to the Clinical Operations function including set-up, maintenance and reconciliation of the Trial Master File for studies.
- Serves as the point of contact for study sites and contract monitors for clinical supplies, document collection and preparation for close-out visits.
- Assists Clinical Operations teams with study set-up (preparation of study materials, Investigator Meeting planning, etc.)
- Develops and keeps Clinical Trial tracking program up to date with site contact, initiation and enrollment details
- Demonstrates a deeper understanding of the science behind Clinical Operations
- Tracking and preparing study-specific information utilizing databases, spreadsheets, and other tools.
- Provide input and assist with harmonization of Clinical Operations databases and tracking tools.
- Assist in the maintaining clinical information and training of Clinical Operations personnel in the clinical trials database
- Processes re-supply drug shipments.
- Order and maintain inventory of clinical supplies.
- Order and ships case report forms.
- Assists with development of documents for site binders. Assembles and coordinates distribution of site binders.
- Serves as CRA back up providing verbal and written communication with study personnel.
- Under close supervision reviews and participates in the quality assurance of data or documents.
- Arranges meeting logistics. Drafts meeting agendas and assists in preparing meeting minutes.
- The position interacts with other departments, as directed, to complete assigned tasks.
- May assist with monitoring visits under the direct supervision of senior staff.
- Travel may be required.
- Assist with the planning and facilitation of investigator meeting and, when applicable, provide on location support during the meetings.
- 2-3+ years of experience with BS degree in a related scientific discipline.
- Travel may be 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 & 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.