Temporary - Clinical Trial Associate
- 111 Oyster Point Blvd, South San Francisco, CA 94080, USA
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases.
We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology.
Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
FivePrime is committed to innovation and outstanding science, values that are reflected in our people and our products. Discover more about FivePrime at www.fiveprime.com.
The Clinical Trial Associate 1 (CTA 1) is accountable for supporting the planning and execution of assigned clinical trials under the direction of the Study Execution Team Leader (SETL), including;
- Assist with managing defined aspects of clinical trials to ensure trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
- Assist clinical study sites with IRB/EC submissions and ensure collection and review of required essential study documents and reports.
- Assist in the creation, maintenance and ongoing quality review of the trial master file (eTMF) to ensure files are properly maintained and up to date, archived and stored under the direction of the SETL.
- Assist with planning investigator meetings and preparing site training materials
- Assist with training internal and external CRAs, CRO team members, and investigative site staff.
- Participate in the preparation of study-specific documentation, e.g. study reference manuals
- Provide logistical support for the SET, scheduling meetings, distributing agendas and minutes
- Track key study activities using tracking tools
- Assist with tracking and analyzing study metrics under the direction of the SETL
- Maintain study team files
- Ensure that supportive study supplies and documents are available (e.g., contracts, IXRS, lab kits, non-clinical supply materials).
- Participate in department process improvement initiatives
- Assist in the review of vendor invoices
- Other projects when assigned
- BS/BA in Life Science or related discipline
- 2+ years industry experience in drug development
- Effective team player and strong interpersonal skills
- Strong verbal and written communication skills in English.
- Attention to detail
- Proficient with word processing, spreadsheet, database, and presentation software and with filing systems.
- Working knowledge of FDA & ICH/GCP regulations and guidelines
- Need to add critical/analytical thinking (rigor)
- Initiative (vigor)
- Innovation and creativity
- Problem solving
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
Five Prime acknowledges that providers may be a valuable resource for identifying and recruiting candidates for employment. However, we require that all recruiters engage directly with Five Prime’s Talent Acquisition Team and comply with Five Prime’s requirements prior to transmitting any resumes/CVs or introducing any candidates to Five Prime. Five Prime’s Talent Acquisition Team is the only function within the Company that can enter into contractual relationships with external recruiters and recruiting agencies. As such, all unsolicited resumes, CVs, anonymous profiles, or candidate information you may submit to employees of Five Prime will become property of Five Prime and Five Prime will have no obligation to pay you or anyone else for the use of such information, including any finder’s, placement, introduction or placement fee.