Temp - Clinical Trial Associate/Senior 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.
We are seeking a highly motivated individual to join the Clinical Operations group. This position is responsible for supporting the study team with study execution and provide logistical support in managing the full scope of clinical trial(s) and coordinating cross-functional team and vendor efforts and ensures the clinical trials are initiated efficiently and completed on time, within budget and in compliance with SOPs, regulations, and ICH/GCP guidelines in accordance with the Clinical Development Plan (CDP).
- Provide logistical support for the Study Execution Team (SET), schedule meetings, distribute agendas and take minutes
- Track key study activities using tracking tools
- Participate in developing and finalizing cross-functional deliverables such as clinical study protocols, CRFs, consent forms, study management plans, study reference manuals, study reports, annual reports and other clinical documents under the direction of the Study Execution Team Lead (SETL)
- Keep track of supportive study supplies and documents to ensure materials are available at all times (e.g. lab kits, non-clinical supply materials)
- Contribute to the development of request for proposals (RFPs) for assigned vendors, review proposals and make award recommendations, participate in selection of vendors under the direction of the SETL
- Create, maintain and conduct ongoing quality review of the trial master file (TMF) to ensure files are properly maintained and up to date, archived and stored
- Assist with planning investigator meetings and develop content and/or site training materials
- Assist with training team members, site monitors and vendors on study protocol and processes
- Contribute to the review and assurance of adequate sub-depot(s) and site study drugs supply (e.g. Investigational Medicinal Product [IMP], placebo and or comparator drugs)
- Assist with monthly money/financial meeting preparation, review of site and vendor invoices and maintain study budget tracking tools to ensure that trial costs are accurately tracked and reported to the SETL
- Coordinate routine and final data listings review, and participate as necessary
The following tasks are only applicable to Sr. CTA:
- Responsible for the day-to-day management of assigned vendors to ensure that project goals are achieved; organize and lead teleconferences with key vendor personnel, facilitate vendor activities and adherence to scope of work and service agreement under the direction of the SETL. Assist with ensuring that clinical data from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled
- Review monitoring reports and monitoring visit letters and escalate issues and risks to SETL
- Coordinate and participate in review of site and study protocol deviations
- Other projects when assigned
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.