Whole Biome is an early-stage, venture-backed biotech located in San Francisco. We are a small team of scientists, engineers and physicians interested in improving human health by using the latest research from diverse fields, such as, microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition sciences.
We are currently seeking a Clinical Coordinator to join Whole Biome’s Clinical Team. As Clinical Coordinator you work directly with the Chief Medical Officer to provide the project management support for allWhole Biome clinical studies. The position will also contribute to study planning, study design, preparation, management, evaluation, and documentation. You will directly interact with the study team and internal resources to drive all clinical studies at Whole Biome. You will also provide clinical scientific input for final study reports and annual report documentation, and assist in documentation processes including communications with IRBs. Additionally, you will have the opportunity to work with the Manufacturing, Molecular Biology, and Compute Teams to support and enable the discovery and development of novel, life-changing microbiome interventions.The successful candidate will be able to learn new systems quickly and adapt to constantly changing needs as Whole Biome rapidly expands capabilities in terms of projects and processes. The successful candidate will welcome the opportunity to coordinate and shephard individuals and internal teams to efficiently and effectively complete clinical trials.
Lead project management for the multi-site, multidisciplinary clinical trials team to ensure all trial deliverables are met within agreed timelines.
Lead clinic design meetings, manage team actions, and actively track study progress to ensure completion according to specified timelines, budget and quality standards. Communicate study progress to the executive team.
Serve as the primary coordinator who manages processes and reporting for the internal team. Suggest internal development when needed.
Work with Chief Medical Officer to refine clinical trial design(s), identify logistical hurdles and propose/implement processes that improve efficiency and communication.
Interact with Chief Medical Officer/Clinical Scientist/clinical labs/vendors to ensure efficient study set up and conduct, reviewing and troubleshooting site performance, protocol deviations and ensure awareness troubleshooting of emerging issues.
Co-author and coordinate the review of Clinical Study Protocols, amendments and related documents, Informed Consent Forms, Study Operations Manuals, monitoring plans, and other study essential documents.
Arrange and coordinate clinical site monitoring visits.
In collaboration with the internal analysis team and clinic sites, manage the ongoing medical/ scientific review of the clinical trial data, and coordinate the data analysis and interpretation for first interpretable results. Oversee the data review and interactions with the Chief Medical Officer, Data Analyst, Statistician, and third parties to ensure high quality data are transferred/available in a timely manner.
Identify areas for process or technology improvements.
Maintain knowledge of regulations and procedures for clinical trials.
REQUIREMENTS: This is a dynamic, start-up environment that requires an individual with adaptability, ingenuity, independent drive, and a passion for improving patient care.
PhD level scientist with life sciences background; PharmD; BSc or MSc in life sciences.
Experience in project or program management, including tracking and tasking tools.
Effective and concise communicator.
At least 5 years of experience running clinical trials to test product efficacy (therapeutic or diagnostic).
Experience in implementing and prioritizing work across multiple projects under tight time constraints.
Experience in establishing the infrastructure required to implement and execute efficient clinical trials.
Knowledge and experience with Good Clinical Practice standards
Knowledge of digital health diagnostic tests and successful implementation.
Demonstrated ability to work independently and be a fully contributing member of a multi-functional fast-paced team environment.
Whole Biome is developing novel classes of therapeutics and diagnostics that target the human microbiome to improve the lives of patients suffering from a variety of diseases. At Whole Biome, we employ cutting-edge technology in our R&D pipeline. We are passionate about building products that are best-in-class and we are looking for individuals who embody that same desire.
At Whole Biome, we understand that success means building great teams to solve challenging problems. We hire the best and brightest and give everyone the resources we need to succeed.
Benefits: - competitive salary and equity packages - health, dental, and vision - 401k with corporate matching - flexible schedules with a focus on work/life balance - unlimited vacation policy (we're all adults and professionals, not clockwatchers) - commuter benefits
Sweet Perks - casual culture (66% of founders usually wearing hoodies) - artisanal coffee - on-site gym - strong belief in work/life balance; we believe it, we encourage it, we live it - pick your own laptop - collaborative, team environment - off-site, team building adventures - walking distance to Caltrain, Muni - walking distance to bars and restaurants in Dogpatch
If you're someone who thrives in a fast-paced environment where autonomy and collaborative teams are equally valued, AND you are excited to dedicate your life to improving health, please get in touch with us! Email email@example.com with your resume and cover letter to begin the application process. Even if you don't see an opening that fits you, please send us your resume if you think your background and personality would be a great fit!