Source Job

• Support the development and refinement of study documents under the guidance of senior clinical scientists.
• Conduct routine clinical data reviews to ensure data quality, completeness, and medical plausibility.
• Partner with clinical scientists, statisticians, and medical directors to extract and interpret scientific data for abstracts, posters, presentations, and manuscripts.

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.

• Directs the operational oversight and execution of clinical site start-up.
• Manages CRO relationship and oversight to ensure appropriate scope of work.
• Develops collaborative relationships with investigative sites.

Bristol Myers Squibb is focused on developing innovative drugs against targets of solid tumors. They are a dynamic biotechnology company headquartered in San Diego, CA, and aim to be the global leader in radiopharmaceuticals.

• Monitor and own the progress of clinical studies at investigative sites.
• Coordinate all necessary activities required to set up and monitor a study.
• Ensure that clinical studies are conducted, recorded, and reported per protocol, SOPs, ICH-GCP, and all applicable regulations and standards.

Precision for Medicine integrates clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences to improve the speed, cost and success rate of bringing life-changing therapies to patients. They have a strong focus on Oncology and Rare Disease and boast extremely high CRA retention rates compared to industry averages.

• 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.

• Oversees all aspects of study site management to ensure patient safety is protected and quality of data is generated.
• Independently conducts all forms of site visits in accordance with the protocol, local laws, ICH-GCP and Precision SOPs.
• Communicates effectively and proactively with both site personnel and Precision Project and Clinical Trial Management.

Precision for Medicine is a precision medicine CRO that combines novel clinical trial designs, operational and medical experts, advanced biomarker and data analytics solutions, and a real passion for complex disease states. They strive to ensure employees feel appreciated through a multitude of benefits and value their ideas and contributions.

• Management and operational delivery of the clinical elements within a trial.
• Successful execution of assigned trials and ensuring completion of trial deliverables.
• Identify challenges to study timelines/deliverables and offer creative action plans.

Precision for Medicine is a precision medicine CRO with a uniquely integrated offering to enable the science of precision medicine. They achieve this by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions. They are dedicated to positively impacting the health and lives of patients around the world, particularly in rare diseases and oncology.

• 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.

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

• Performs on-site or remote monitoring visit activities.
• Identifies investigators and verifies qualifications and resources.
• Trains investigational site staff and supports regulatory submissions.

Ergomed is a rapidly expanding full-service mid-sized CRO specializing in Oncology and Rare Disease. The company has operations in Europe, North America, and Asia, fostering an international culture with employee well-being and career development opportunities.

• 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.

• Manages central laboratory and specialty vendors across clinical trials.
• Provides support for sample related matters to clinical study teams.
• Assists with vendor selection and oversight.

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.

• Support development and communication of medical plans.
• Lead the development and dissemination of scientific and medical data.
• Build and maintain strong relationships with KOLs, researchers, and patient advocacy groups.

Jade Biosciences is focused on developing innovative therapies for autoimmune diseases. They are developing JADE101 to treat IgAN and have a second development candidate as well as an undisclosed antibody discovery program in preclinical development.

• Assist with the development of the protocol and informed consent form and/or program design.
• Manage vendor budgets, payments, and timelines.
• Effectively track and report on internal project metrics and study progress.

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.

• Coordinate and assist with trial start-up activities.
• Facilitate resolution of laboratory queries.
• Track and report on study progress.

Freenome is dedicated to changing the landscape of cancer through early detection. They value diversity and do not discriminate based on various statuses protected by law.

• Support management of contract laboratories and milestones.
• Oversee stability programs and data analysis.
• Author analytical CMC sections of regulatory filings.

Definium Therapeutics, formerly known as Mind Medicine, is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Founded in 2019 and continuously expanding, they are constantly searching for high-impact individuals to strengthen their patient-centric team.

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.

• 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.

• 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.

• Responsible for supporting the Programming deliveries of a clinical study or project.
• Implements statistical programming aspects of the protocol and the clinical development program.
• Ensures high quality is built into own deliverables and the quality delivered by other programmers.

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. They have over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific and focus on quality, professional development, and a supportive culture.

• Designing, configuring, testing, and supporting eDC systems that meet the data collection needs of study protocols.
• Influencing study design, data capture, and compliance with Good Clinical Practice (GCP) standards and FDA/CVM regulations.
• Maintaining thorough documentation, validation reports, and data dictionaries.

Loyal is a clinical-stage veterinary medicine company developing drugs intended to extend the lifespan and healthspan of dogs. Loyal's team includes scientists, veterinarians, engineers, operators, and creatives, and they are a well-funded startup in growth mode.