FLX Bio is a biotechnology company focused on the discovery and development of novel drugs that will improve and prolong the lives of people with cancer. The company is led by a group of seasoned researchers from the biotechnology and pharmaceutical industries and is supported by several of the nation’s premier life sciences venture capital firms. The company is located in the San Francisco Bay area, in the heart of the world’s largest biotechnology research hub. We offer a competitive compensation and benefits package, including aggressive participation in the growth of the company in the form of stock option grants.
Together with the Director of Clinical Operations, the Clinical Research Associate (CRA) will provide day-to-day clinical operations oversight and support for all FLX Bio clinical trials. This cross-functional role involves working directly with the study team, as well as external support staff and vendors, to ensure execution on the clinical strategy and delivery of high-quality clinical trial data. The suitable candidate will work under minimum supervision and contribute technical and operational expertise to achieve FLX’s Clinical Development goals.
Supports/Leads the set-up and on-time execution of clinical study tasks, while ensuring the trial is conducted to FLX quality standards and in compliance with the protocol, SOPs, ICH-GCP, and applicable regulatory requirements
Collaborates with cross functional teams to ensure effective delivery of the assigned activities to meet project milestones
Supports/Leads identification, selection and contracting of study vendors/CROs and development of vendor scope of work (SOW)
Writes/Contributes to clinical trial protocols and protocol-associated documents including Informed Consent Forms and other documents as needed or requested
Supports/Leads the creation/development and review of clinical study plans (Clinical Monitoring Plans, Data Management Plans, Safety Management Plans, Communication Plans, etc.), and other project/study-related documents including training materials, forms, logs, presentations, etc.
Acts as primary point of contact for vendors, investigational sites and cross functional teams
Participates in specification development, design, set-up and UAT of trial infra-structure systems (EDC, IRT, CTMS, ePRO, etc.)
Works closely with FLX Bio Biology staff and external personnel (Central Labs, specialty labs, trial site labs, etc.) on clinical laboratory activities including specimen management & logistics, data management, and issue identification and resolution
Collaborates with Supply Chain personnel to forecast investigational product needs and identify distribution, storage, and accountability requirements
Collaborates with Finance personnel to provide financial information related to clinical development, including budget forecasts and updates
Performs/Leads in-house review of clinical data listings for completeness and accuracy and escalates issues to the vendor and FLX internal team, as needed
Manages clinical monitoring activities, overall site performance, and ensures compliance with Good Clinical Practices (GCP) and applicable regulations
Reviews monitoring trip reports and ensures follow-up of action items to resolution
Responsible for ongoing review of TMF and Sponsor records
Organizes and manages internal team meetings, investigator meetings, and other trial-specific meetings as required
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
BA/BS or equivalent degree (in a scientific discipline or related healthcare field is preferred but is not required)
5-8 years of clinical trial experience in a pharmaceutical, biotechnology, and/or CRO (on-site monitoring experience is a plus)
Demonstrated experience in core and technical aspects of supporting phase 1-3 clinical trials (experience in global trials preferred)
Strong understanding of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines
In-depth knowledge of PC operating systems; Microsoft Office, including MS Word, MS Excel, MS PowerPoint, MS Project, MS Publisher, MS Outlook
Good working knowledge of eClinical products/systems and vendors including EDC, CTMS, IXRS/IRT, eTMF, ePRO, etc.
Strong interpersonal and communication skills (verbal and written); effective in interaction and collaboration with senior and junior colleagues, both internal and external
Ability to work on complex projects and perform multiple tasks, often with tight timelines and with minimal supervision
Ability to creatively approach challenges and problem resolution to optimize the conduct of clinical trials
Experience in oncology is a plus
Domestic and International travel may be necessary