Location: Foster City, CA
Position Type: Initial 6 Month Contract (full-time hours, W2)
Estimated pay rate: $40-$50/hr DOE!
For immediate consideration, please scroll down to the bottom of application for contact information and more!
- Must meet all requirements for Clinical Trials Management Associate position and have demonstrated proficiency in all relevant areas.
- With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required.
- Assures site compliance with the routine protocol and regulatory requirements and quality of data.
- Assists in the setting and updating of study timelines.
- Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors.
- Drafts and coordinates review of protocols, informed consents, case report forms and monitoring plans.
- Assists in the review of routine data and preparation of safety, interim, and final study reports, and resolution of data discrepancies.
- Participates or effectively runs meetings and conference calls with CROs, vendors, and multi-functional teams.
- May participate in abstract presentations, oral presentations and manuscript development.
- Interfaces with individuals in other functional areas to address routine study issues.
- May be asked to assist in the training of Clinical Research Associates and Clinical Project Assistants.
- Under general supervision, participates in two or more departmental or interdepartmental strategic initiatives.
- Working knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Working knowledge and experience with Word, PowerPoint and Excel.
- Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures.
- Ability to develop tools and processes that increase measured efficiencies of the project.
- Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
- Must have a general understanding of functional issues and routine project goals from an organizational perspective
Serious candidates, please answer the following questions after applying. Please email directly to: email@example.com
1. Briefly explain your experience with FDA regulations, EMEA Regulations, ICH Guidelines, and/or GCPs.
2. List your experience within Clinical Trials and when/where you gained that experience.
3. How familiar you are with the commute to Foster City, CA. Note: if you are nonlocal please explain your connection to Foster City and why you are specifically looking at the Bay Area.