Source Job

• Provide high level logistical support for clinical study operations, including study start up, study supplies, site qualification, site initiation, site management, study monitoring, and close out for clinical research studies and collaborations
• Develop study-related documents with minimal Clinical Trial Manager guidance including: protocol, informed consent forms, training materials, protocol amendments, monitoring plans, synopses, and ethics committee submissions, as required
• Manage small to medium size study contracting, budget, invoicing and payment process for all clinical trial vendors including investigative sites with minimal oversight

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other.

• Manage and drive continuous process improvement initiatives.
• Oversee all daily, end to end, clinical trial/patient matching operations.
• Serve as a liaison between trial sites, sponsors, and drive project delivery.

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for their work and each other.

• Contributes to the development of clinical trial protocols, including patient selection criteria, study endpoints, and data collection methods.
• Monitors the data of clinical trials at study sites, ensuring adherence to protocols and good clinical practice (GCP) guidelines.
• Maintains knowledge of the therapeutic area, disease state, and potential drug effects.

Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition. As they build their core team, they're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger and passionate about making a difference to an engaged, inclusive, and positive company culture.

• Develop, review, and update study-related training materials and documents.
• Serve as Subject Matter Expert for clinical sites and provide guidance on protocol interpretation and eligibility requirements.
• Partner with field Clinical Research Associates (CRAs) and CTAs to resolve issues identified during site visits.

ImmunityBio is a commercial-stage biotechnology company focused on developing cell and immunotherapy products designed to strengthen the immune system to eliminate cancerous or infected cells. They are publicly traded with headquarters in Southern California, working collaboratively to transform the lives of patients.

• Leads data management activities for phase 1-4 studies.
• Manages and monitors progress with CROs and vendors.
• Reviews protocols for appropriate data capture and eCRF design.

Iovance Biotherapeutics is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, their employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law.

• Assist with daily site activities, acting as the primary point of contact for the site.
• Assist with training and mentoring research staff, upholding professional development goals.
• Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.

Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.

• Provide high-quality meeting support for committees and ad hoc working sessions.
• Oversee clinical knowledge and protocol content across Notion and Google Drive.
• Coordinate timelines, communicate with cross-functional stakeholders, and help teams stay aligned.

Midi Health is on a mission to transform care for women in midlife. They are building a best-in-class team while working with smart, purpose-driven people.

• Provide leadership for the Data Management group and ensure quality data.
• Oversee DM vendors' deliverables and maintain strong collaboration.
• Create procedures for data collection, review, and cleaning processes.

Definium Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for brain health disorders. They aim to be a global leader in delivering innovative treatments to improve patient outcomes and are expanding their global presence.